Auteur en jaartal

Redenen van exclusie

Kazemi, 2002

Narrative review

Shashua, 2000

Narrative review

Fudalej, 2011

Intervention not well described

Williams, 2003

Wrong comparison

Mueller, 2012

Incorrect intervention

Schultze-Mosgau, 2003

did not present data on the effect size or association for the outcomes of interest

Van der Meij, 2001

did not present data on the effect size or association for the outcomes of interest

Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison / control (C) ³

Follow-up

Outcome measures and effect size ⁴

Comments

Nishihara, 2014

Type of study:

Retrospective cohort study

Setting:

University hospital

Country:

Japan

Source of funding:

Not reported

Inclusion criteria:

Complete unilateral cleft lip and palate who underwent

SABG in the alveolar cleft from March 1991 to

December 2002.

Exclusion criteria:

Patients with congenital malformation, with the cleft-adjacent lateral incisor, or with incomplete cleft lip.

N total at baseline:

Intervention: 16

Control: 9

Important prognostic factors²:

Age in years range:

I: 7.2 to 13.3

C:10.3 to 17.8

Groups comparable at baseline?

The canine angle was significantly smaller in the intervention group.

I: Secondary autogenous bone grafting before eruption of the canine according to Bergland methods.

C: Secondary autogenous bone grafting before eruption of the canine. Canine teeth had almost erupted at the time of bone grafting according to Bergland methods.

Length of follow-up:

I: 12.9 years (range 9.7 to 20.2)

C: 11 years (range 9.1 to 14.8)

Measurement took place at 1 year and more than 4 years after the operation

Loss-to-follow-up:

I: 0

C: 0

Crown eruption at 4 years:

I: 15/16 (94%)

C: 9/9 (100%)

Vertical heights at > 4 years:

I: 56.8 ± 5.1 mm

C: 56.7 ± 4.2 mm

P>0.05

Rate of an acceptable bone bridge:

I: 62.5%

C: 88.8%

P-value=0.158

Trindade-Suedam, 2012

Type of study:

Prospective cohort study

Setting:

University hospital

Country:

Brazil

Source of funding:

Govermental (CAPES within the PRODOC program)

Inclusion criteria:

Patients with complete unilateral cleft lip and palate operated on for a period of 3 months (February to May 2009), who underwent alveolar

bone grafting

Exclusion criteria:

No return for the second or third examination.

N total at baseline:

Total group: 52 (not specified per group)

N in the analysis:

Intervention: 16

Control: 15

Important prognostic factors2:

None described

Groups comparable at baseline?

As a definition of the study design, groups were not comparable on age. Unsufficient information was provided on other clinical characteristics.

SABG group: patients during

mixed dentition operated on before or immediately after eruption of the permanent canine (10-13 y).

All surgical procedures were performed according to the protocol proposed by Boyne and Sands (1972), in which particulate bone from the iliac crest was harvested.

TABG group: patients during permanent dentition

(15-28y)

All surgical procedures were performed according to the protocol proposed by Boyne and Sands (1972), in which particulate bone from the iliac crest was harvested

Length of follow-up:

2 months and 6-12 months

Loss-to-follow-up:

Total group: 19 (37%)

Reasons Nineteen patients were excluded because they did not return for the second or third examination. In 2 instances, patients did not return because of extrinsic trauma to the bone graft resulting in complete bone loss.

Modified Bergland Index 1=excellent - 5=failure

(95% CI):

Buccal 2 months

SAGB: 1.50 (0.63)

TABG: 2.53 (1.64)

Buccal 6-12 months

SAGB: 1.38 (0.50)

TABG: 2.93 (1.49)

P<0.05

Intermediate 2 months

SAGB: 1.56 (1.03)

TABG: 2.60 (1.59)

P<0.05

Intermediate 6-12 months

SAGB: 1.75 (1.18)

TABG: 2.93 (1.44)

P<0.05

Palatal 2 months

SAGB: 1.63 (1.09)

TABG: 2.67 (1.63)

P<0.05

Palatal 6-12 months

SAGB: 1.63 (1.09)

TABG: 2.80 (1.52)

P<0.05

Bergland index 2 months (excellent/good):

SAGB: 14 (86%)

TABG: 9 (60%)

Bergland index 6-12 months (excellent/good):

SAGB: 12 (75%)

TABG: 8 (53%)

Bergland index 2 months (failure):

SAGB: 0 (0%)

TABG: 4 (26%)

Bergland index 6-12 months (failure):

SAGB: 0 (0%)

TABG: 4 (26%)

A post-hoc sub-group analysis was performed which was not pre specified in the methods section. A rational for the chosen cut off was missing.

“TABG group subdivided into 2

groups according to age (patients 15-16 and 18-28 y), no patients classified as having failure conditions were observed in the first subgroup (15-16 y). In the second subgroup (18-28 y), 44% were ranked as having failure conditions.”

They put much weight on this subgroup analysis in the discussion and conclude that surgery performed at younger ages (15-16 y), even during

permanent dentition, yields better outcomes.

Miller, 2010

Type of study:

Retrospective cohort study

Setting:

University hospital

Country:

United States

Source of funding:

US government work

Inclusion criteria:

Patients undergoing alveolar cleft bone grafting from 2000 to 2008.

Exclusion criteria:

Not described.

N total at baseline:

Intervention: 61

Control: 38

Important prognostic factors²:

Mean age in years (range):

Total group: 8.8 (range 6 to 37)

Gender % male:

Total group: 68%

Groups comparable at baseline?

No statistically significant differences (P <.05) were found between groups 1 and 2 in gender, ethnicity, cleft type, hospital stay, or length of follow-up. As a definition of the study design, groups were not comparable on age.

I: Grafting before complete eruption of the permanent central incisors

C: Grafting during or after complete eruption of the permanent central incisors

Length of follow-up:

Variable between 1 week to 52

months

Loss-to-follow-up:

28% (71 had appropriate imaging available no further information described).

Complications:

I: 9.8% (pyogenic granuloma n=2, residual fistula n=2, residual alveolar defect without fistula n=1, and hip wound dehiscence n=1).

C: 13.2% (residual fistula n=3, residual, alveolar cleft defect without fistula n=1, gingival hyperplasia n=1, and fibroma n=1).

No statistically significant differences

The proportions of complication were on patient level. One patient with multiple complications was measured as one to calculate the percentage. This was present for one patient in the control group who must have had two complications.

Rawashdeh, 2007

Type of study:

Prospective cohort study

Setting:

University hospital

Country:

Jordan

Source of funding:

Not reported

Inclusion criteria:

Not described

Exclusion criteria:

The requirement for postoperative follow-up period was a minimum of 6 months.

N total at baseline:

Intervention: 30

Control: 32

Important prognostic factors²:

Mean age in years ± SD:

I:10.3 ±?

C:16.5 ±?

Groups comparable at baseline?

As a definition of the study design, groups were not comparable on age. Unsufficient information was provided on other clinical characteristics.

I: Early SABG (before the eruption of the canine). The surgical technique utilized was based on principles of SABG described by Boyne and Sands. The bone used was autogenous cancellous bone harvested from the iliac crest.

C: Late SAGB (after the eruption ofthe canine). The surgical technique utilized was based on principles of SABG described by Boyne and Sands. The bone used was autogenous cancellous bone harvested from the iliac crest.

Length of follow-up:

Average 2.8 years (range 0.6 to 5.5 years)

Loss-to-follow-up:

Not described

Incomplete outcome data:

Not described

Bony fill measured with the Kindelan grading scale:

Unilateral cleft patients:

Grade 1:

I: 20 (90%)

C: 20 (80%)

Grade 2:

I: 1 (5%)

C: 3 (12%)

Grade 3:

I: 1 (5%)

C: 2 (8%)

Grade 4:

I: 0 (0%)

C: 0 (0%)

Bilateral cleft patients:

Grade 1:

I: 9 (56.2%)

C: 8 (57.1%)

Grade 2:

I: 3 (18.8%)

C: 2 (14.3%)

Grade 3:

I: 2 (12.5%)

C: 0 (0%)

Grade 4:

I: 2 (12.5%)

C: 4 (28.6%)

Only grade 1 SABG cases, which corresponded

to Bergland types I and II, and Chelsea19 types A

and C, were classified successful.

There were no tests performed that evaluated the statistical difference between groups.

Jia, 2006

Type of study:

Prospective cohort study

Setting:

University hospital

Country:

China

Source of funding:

Not reported

Inclusion criteria:

Patients with clefts who had secondary alveolar bone grafting between 1992 and 2001.

Exclusion criteria:

No follow-up or the cleft canine had not erupted at the time of the research.

N total at baseline:

Total group: 202

After exclusion of follow-up:

Total group: 170

I (CLAP): 16

C (CLAP): 24

I (UCLP): 44

C (UCLP): 58

I (BCLP): 22

C (BCLP): 34

Important prognostic factors²:

age (range)

CLAP(all): 14 (8-33)

UCLP(all): 15 (8-35)

BCLP(all): 14 (8-24)

Gender % male:

CLAP(all): 47.5%

UCLP(all): 58.8%

BCLP(all): 64.3%

Groups comparable at baseline?

Patients characteristics were not specified for the contrast of interest (intervention at early vs. late eruption). As a definition of the study design, groups were not comparable on age.

I: Secondary alveolar bone grafting before eruption of the canine according to the standardised method that was first described by Boyne and Sands.

Subgroups for:

CLAP: unilateral cleft lip and alveolar process alone

UCLP: unilateral cleft lip and palate

BCLP: bilateral cleft lip and palate.

C: Secondary alveolar bone grafting after eruption of the canine according to the standardised method that was first described by Boyne and Sands.

Subgroups for:

CLAP: unilateral cleft lip and alveolar process alone

UCLP: unilateral cleft lip and palate

BCLP: bilateral cleft lip and palate.

Length of follow-up:

Average 1.9 years (range 1 to 8 years).

Loss-to-follow-up:

Not described

Incomplete outcome data:

Not described

Interdental septal height. Success rate defined as Bergland Type I and II

(p-value provide for significant results):

CLAP

I: 15 (94%)

C: 23 (96%)

UCLP

I: 42 (95%)

C: 48 (83%)

P-value = 0.049

BCLP

I: 20 (91%)

C: 23 (68%)

p-value = 0.044

Interdental septal height. Failure rate defined as Bergland Type III and IV

(p-value):

CLAP

I: 1 (6%)

C: 1 (4%)

UCLP

I: 2 (5%)

C: 10 (17%)

BCLP

I: 2 (9%)

C: 11 (32%)

Complications:

Chronic infection of the graft, resulting in complete failure

I: 1

C:5

Minor wound dehiscences were reported too, but it was not specified in which group they had appeared.

Patients with complications had poor postoperative oral hygiene.

Dempf, 2002

Type of study:

Retrospective cohort study

Setting:

University hospital

Country:

Germany

Source of funding:

Not reported

Inclusion criteria:

Patients, who underwent an alveolar bone grafting at least 3 years ago.

Exclusion criteria:

Spontaneous approximation of the jaw segments tertiary osteoplasties needed to be performed only on those patients who had not already received a systematic therapy.

N total at baseline:

Total group: 140 procedures in 91 patients

Important prognostic factors²:

Mean age in years ± SD:

I:10.6 ± ?

C: 21.3 ± ?

Groups comparable at baseline?

Unclear, unsufficient information was given on patient characteristics. As a definition of the study design, groups were not comparable on age.

I: Secondary bone grafting during the mixed stage of dentition with autogenous iliac cancellous bone.

Osseous bridging of the clefted alveolus was attempted as a secondary osteoplasty in patients aged between 8 and 11 years in all cases in which a spontaneous approximation of the jaw segment had not occurred.

C: Tertiary bone grafting after completion of the second stage of dentition with autogenous iliac cancellous bone.

Osseous bridging of the clefted alveolus was attempted as a secondary osteoplasty in patients aged between 8 and 11 years in all cases in which a spontaneous approximation of the jaw segment had not occurred.

Length of follow-up:

Not described

Loss-to-follow-up:

Total group: 39.3% (procedure level)

Reasons not described.

Incomplete outcome data:

Bone Height:

I: 4 (6.7%)

C: 0 (0%)

Reason not described.

Oronasal fistulae:

I: 0

C: 0

Bone Height 75-100%:

I: 25 (41.7%)

C: 10 (40.0%)

Bone Height 50–75%:

I: 26 (43.3%)

C: 7 (28.0%)

Bone Height 25–50%:

I: 4 (6.6%)

C: 6 (24.0%)

Bone Height 0–25%:

I: 1 (1.7%)

C: 2 (8.0%)

Infraocclusion:

I: 12 (48.0%)

C: 14 (70.0%)

No. infraocclusion:

I: 13 (52.0%)

C: 6 (30.0%)

Loss of the dental implant:

I: 0

C: 5

Complete loss of the

grafted material was not observed.

Freihofer, 1993

Type of study:

Retrospective cohort study

Setting:

University hospital

Country: The Netherlands

Source of funding:

Not reported

Inclusion criteria:

All patients with reconstructions of unilateral clefts and of clefts in patients with a bilateral deformity, with a follow-up time of at least 1 year and adequate documentation.

Exclusion criteria:

Patients with missing records or when it was not possible to reasonably incorporate them in one of the groups (unilateral cleft or cleft)

N total at baseline

Unilateral clefts (number of cleft sides):

Intervention: 61

Control 1: 21

Control 2: 64

Control 3: 19

N total at baseline

Bilateral clefts (number of cleft sides):

Intervention: 32

Control 1: 21

Control 2: 46

Control 3: 32

Important prognostic factors²:

Not reported

Groups comparable at baseline?

Unclear, unsufficient information was given on patient characteristics. As a definition of the study design, groups were not comparable on age.

I: Early secondary bone grafting. Reconstruction of the alveolar cleft before eruption of the canine through the alveolar bone. Transplant materials were mandibular symphysis, rib or iliac crest and one heterogeneous group containing calvarial bone, bone from the vomer, bank bone, lyodura and closures without a transplant.

C1: Late secondary bone grafting. Reconstruction of the alveolar cleft after eruption of the canine through the alveolar bone.

C2: Late secondary bone grafting. Reconstruction of the alveolar cleft after eruption of the canine through the alveolar bone simultaneously with a midface osteotomy (defined as a (partial) Le Fort I or higher).

C3: Tertiary bone grafting. Reconstruction of the alveolar cleft when secondary or closure during the osteotomy had failed.

Transplant materials were mandibular symphysis, rib or iliac crest and one heterogeneous group containing calvarial bone, bone from the vomer, bank bone, lyodura and closures without a transplant.

Length of follow-up:

At least one year (no further information reported).

Loss-to-follow-up:

No loss to follow-up as availability of one year follow-up was part of the inclusion criteria.

Incomplete outcome data:

No incomplete outcome data as availability of data for one year follow-up was part of the inclusion criteria.

Success rate defined as no oronasal communication and with at least 50 % of the

bone graft height (unilateral clefts):

I: 56/61 (92%)

C1: 15/21 (71%)

C2: 33/64 (52%)

C3: 12/19 (62%)

Success rate defined as no oronasal communication and with at least 50 % of the bone graft height (bilateral clefts):

I: 29/32 (91%)

C1: 15/21 (71%)

C2: 18/46 (39%)

C3: 10/32 (31%)

Difference in success rate between time points (all clefts):

Early grafting (Intervention) was significantly better than at all other points in time.

The positive or negative effects of pre- and/or postoperative orthodontics were not studied.

Early secondary grafting of the alveolar cleft has a success rate of more than 90 % and is significantly better compared with all other timings.

The treatment procedure, using rib, chin, ilium, or other bone for grafting, varied between patients, which might has affected the outcome.

Surgeons closing bilateral clefts were more experienced than those closing unilateral ones.

Sindet-Pedersen, 1985

Type of study:

Retrospective cohort study

Setting:

Community hospital

Country:

Denmark

Source of funding:

Not reported

Inclusion criteria:

Patients diagnosed with cleft lip and alveolar process only, unilateral cleft lip palate and bilateral clefts involving the alveolar process with residual cleft in the alveolar process operated by secondary or late secondary bone-grafting.

Exclusion criteria:

Edentulous premaxilla, lack of

follow-up (not specified), and atypical cleft diagnoses.

N total at baseline

Cleft lip and alveolar process only:

Intervention: 19

Control 1: 11

Control 2: 2

N total at baseline

Unilateral cleft-lip and palate:

Intervention: 61

Control 1: 70

Control 2: 67

N total at baseline

Bilateral cleft-lip and palate:

Intervention: 16

Control 1: 24

Control 2: 23

Important prognostic factors²:

Mean age (range):

I: 9.6 (5 – 14)

C1: 13.5 (11 – 15)

C2: 20.9 (16 – 38)

Gender:

I: 73% M

C1: 71% M

C2: 68% M

Minor oral surgery

I: 58 (60%)

C1: 43 (41%)

C2: 25 (27%)

Groups comparable at baseline?

As a definition of the study design, groups were not comparable on age. Unsufficient information was provided on other clinical characteristics.

I: Secondary bone grafting

before eruption of the canine

Before bone-grafting, all patients underwent orthodontic treatment including transversal and/or sagittal expansion of the maxilla

C1: Secondary bone-grafting after eruption of the canine

C2: Late secondary bone-grafting

Before bone-grafting, all patients underwent orthodontic treatment including transversal and/or sagittal expansion of the maxilla

Length of follow-up:

Average 7.2 months (range from 5.5 to 8.5 months)

Loss-to-follow-up:

20/313 patients were excluded, with loss to follow amongst the reasons for exclusion. The exact number or reason for loss are not described.

Marginal bone level on teeth adjacent to the cleft. Total dental rehabilitation score value (1=optimal, 2=acceptable, 3=unacceptable, 4=no possibility of total dental rehabilitation):

Cleft lip and alveolar process only mean score value*:

I: 1.05

C1: 1.00

C2: 1.00

Unilateral cleft-lip and palate mean score value*:

I: 1.10

C1: 1.41

C2: 1.58

Bilateral cleft-lip and palate mean score value*:

I: 1.16

C1: 1.58

C2: 1.96

Cleft lip and alveolar process only mean score value*:

I: 100%

C1: 100%

C2: 100%

Unilateral cleft-lip and palate success rate*:

I: 98.4%

C1: 88.6%

C2: 77.6%

Bilateral cleft-lip and palate mean score value*:

I: 100%

C1: 75%

C2: 60.9%

Cleft lip and alveolar process only recurrence of fistula*:

I: 0

C1: 0

C2: 0

Unilateral cleft-lip and palate recurrence of fistula *:

I: 0

C1: 3

C2: 10

Bilateral cleft-lip and palate recurrence of fistula *:

I: 0

C1: 1

C2: 11

*The results were presented on cleft level. Therefore the presented numbers exceed the number of included patients.

Variation in treatment result between the 3 groups is statistically significant calculated by means of the "Chi-square test" for unilateral cleft-lip palate, and for bilateral clefts calculated on the basis of the number of clefts as well as the number of patients.

Study reference

(first author, year of publication)

Bias due to a non-representative or ill-defined sample of patients?¹

(unlikely/likely/unclear)

Bias due to insufficiently long, or  incomplete follow-up, or differences in follow-up between treatment groups?²

(unlikely/likely/unclear)

Bias due to ill-defined or inadequately measured outcome ?³

(unlikely/likely/unclear)

Bias due to inadequate adjustment for all important prognostic factors?⁴

(unlikely/likely/unclear)

Nishihara, 2014

Likely: patient characteristics determined the timing of treatment. This leads to confounding by indication. Other characteristics were poorly described.

Unlikely: no patients were missing at follow up.

Likely: the outcome assessor could not be blinded for the timing of the intervention (radiographic pictures will show eruption).

Likely: there was no adjustment for prognostic factors.

Trindade-Suedam, 2012

Likely: patient characteristics determined the timing of treatment. This leads to confounding by indication. In addition, participants were selected based on their follow up period (31 out of the initial 52). For two drop-outs the reason was known to be related to the outcome of the intervention. Other characteristics were poorly described.

Unlikely: as a result of the inclusion criteria, there was a complete follow up.

Likely: the outcome assessor could not be blinded for the timing of the intervention (radiographic pictures will show eruption).

Likely: there was no adjustment for prognostic factors.

Miller, 2010

Likely: patient characteristics determined the timing of treatment. This leads to confounding by indication. Other characteristics were poorly described.

Likely: a substantial proportion of data was missing, without a specified reason.

Likely: the outcome assessor could not be blinded for the timing of the intervention (radiographic pictures will show eruption).

Likely: there was no adjustment for prognostic factors.

Rawashdeh, 2007

Likely: patient characteristics determined the timing of treatment. This leads to confounding by indication. In addition, participants were selected based on their follow up period which can introduce selection bias. No inclusion criteria were specified.

Unlikely: as a result of the inclusion criteria, there was a complete follow up.

Likely: the outcome assessor could not be blinded for the timing of the intervention (radiographic pictures will show eruption).

Unlikely: subgroups were defined for unilateral and bilateral palates.

Jia, 2006

Likely: patient characteristics determined the timing of treatment. This leads to confounding by indication. Additionally, participants were selected based on their follow up period (170 out of 202) which can introduce selection bias. Other characteristics were poorly described.

Unlikely: as a result of the inclusion criteria, there was a complete follow up.

Likely: the outcome assessor could not be blinded for the timing of the intervention (radiographic pictures will show eruption).

Unlikely: subgroups were defined for alveolar process alone, unilateral and bilateral palates.

Dempf, 2002

Likely: patient characteristics determined the timing of treatment. This leads to confounding by indication. Other characteristics were poorly described.

Likely: a substantial proportion of data was missing.

Likely: the outcome assessor could not be blinded for the timing of the intervention (radiographic pictures will show eruption).

Likely: there was no adjustment for prognostic factors.

Freihofer, 1993

Likely: patient characteristics determined the timing of treatment. This leads to confounding by indication. Other characteristics were poorly described. In addition, reconstructions were selected based on minimal follow up documentation of one year (“a few patients are not incorporated in the series, mostly being adults who were not follow-up routinely”).

Unlikely: no patients were missing at follow up.

Likely: the outcome assessor could not be blinded for the timing of the intervention (radiographic pictures will show eruption).

Unlikely: subgroups were defined for unilateral and bilateral palates and for different bone grafting material (chin, rib, ilium, other).

Sindet-Pedersen, 1985

Likely: patient characteristics determined the timing of treatment. This leads to confounding by indication. Other characteristics were poorly described.

Unlikely: 20 out of 313 patients were excluded for different reasons (edentulous premaxilla, lack of follow-up, atypical diagnosis).

Likely: the outcome assessor could not be blinded for the timing of the intervention (radiographic pictures will show eruption).

Unlikely: subgroups were defined for unilateral and bilateral palates and for different types of surgery.