Long-term functional outcomes of primary cleft surgery
| ISRCTN | ISRCTN24136967 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24136967 |
- Submission date
- 30/03/2022
- Registration date
- 30/03/2022
- Last edited
- 22/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Reconstruction of the alveolar process (the thick ridge of bone that contains the tooth sockets) and its adjacent platform is the final step in surgery for patients with a cleft palate. The aim of this study is to assess the success rate of autogenous mid-secondary alveolar bone grafting.
Who can participate?
Patients with a cleft palate operated on at Universitair Ziekenhuis Brussel between 1991 and 2020
What does the study involve?
Patients' charts are analysed to assess the success of the bone grafting.
What are the possible benefits and risks of participating?
No risks are expected. Based on the results the researchers can assess and improve treatment if needed.
Where is the study run from?
Universitair Ziekenhuis Brussel (Belgium)
When is the study starting and how long is it expected to run for?
May 2018 to December 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Ana Tache
ana.tache@uzbrussel.be
Contact information
Principal Investigator
Laerbeeklaan 101
Brussels
1090
Belgium
| Phone | +32 (0)494 17 73 25 |
|---|---|
| ana.tache@uzbrussel.be |
Study information
| Study design | Retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Success rate of mid-secondary alveolar cleft reconstruction using anterior iliac bone grafts: a retrospective study |
| Study acronym | LTFOPCS |
| Study objectives | The aim of this study is to assess the success rate of autogenous mid-secondary alveolar bone grafting following a standardized protocol. |
| Ethics approval(s) | Approved 02/05/2018, Institutional Research Ethics Board of Vrije Universiteit Brussel (Commissie Medische Ethiek (0.G. 016), Reflectiegroep Biomedische Ethiek, Laarbeeklaan 101, 1090 Brussel, Belgium; +32 (0)2 477 55 84; commisie.ethiek@uzbrussel.be), ref: B.U.N. 143201836187 |
| Health condition(s) or problem(s) studied | Veau III and Veau IV cleft palate |
| Intervention | Alveolar repair through iliac bone graft took place as warranted at 8-11 years of age to accommodate canine eruption and development, along with premaxillary repositioning osteotomy of bilateral complete clefts. In some cases, early bone grafting was performed prior to the eruption of cleft-side lateral incisors. Presurgical orthodontics (fixed or removable Hyrax or Haas expander) served to expand and align the maxillary arch in advance of these grafts. As of 2012, a collagen biomatrix (TissuDura; Baxter AG, Vienna, Austria) was applied at times (not routinely) below the repaired nasal layer (Vicryl 5-0; Ethicon, Somerville, NJ, USA) and stabilized by adding fibrin sealant (Tisseel; Baxter). Bone marrow was aspirated from the iliac crest using a 50-mm Jamshidi needle (Handlex; Medax, Poggio Rusco, Italy). Cancellous bone was harvested through a medially based trap-door technique from the anterior iliac crest (Video) with the use of Champy 8 mm and 5 mm Bone Biopsy Instruments (KLS Martin Group, Tuttlingen, Germany). The harvested bone was particulated using a bone mill and mixed with bone marrow aspirate; afterwards, was syringe-condensed into the alveolar cleft and manually molded. After suturing of oral mucosa (Vicryl 4/0), fibrin sealant was employed to affix the mucoperiosteal flaps onto the transplanted bone. A nasal packing with an inner airway tube (Ivalon; First Aid Bandage Company, New London, CT, USA) was inserted and remained in place until hospital discharge (average, 2 days). At the donor site, a continuous anesthetic elastomeric pump (Baxter International Inc, Deerfield, IL, USA) was placed. Patients were discharged wearing the pump as a pouch, which was removed 3 days postoperatively (on average). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Success rate of autogenous mid-secondary alveolar bone grafting assessed using patient charts from between 1990 and 2020. Criteria for success were: long-term preservation of alveolar bone stock, ability of spontaneous or orthodontic-guided eruption and periodontal health of permanent lateral incisors and canine teeth, absence of exposed root structures for teeth adjacent to clefts, absence of fistula and successful placement of osseointegrated implants as warranted. Failure of alveolar bone grafts was indicated by radiographically demonstrable total or near-total graft loss requiring reintervention. |
| Secondary outcome measures | There were no secondary outcome measures |
| Overall study start date | 02/05/2018 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 124 |
| Total final enrolment | 124 |
| Key inclusion criteria | All cleft patients receiving secondary alveolar bone grafts between 1991 and 2020 were reviewed |
| Key exclusion criteria | 1. Lost to follow-up 2. Incomplete files |
| Date of first enrolment | 01/01/1991 |
| Date of final enrolment | 31/12/2020 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Brussels
1090
Belgium
Sponsor information
Hospital/treatment centre
Laerbeeklaan 101
Brussels
1090
Belgium
| Phone | +32 (0)2 477 41 11 |
|---|---|
| ana.tache@uzbrussel.be | |
| Website | http://www.uzbrussel.be/u/view/en/17362-Home.html |
"ROR" |
https://ror.org/038f7y939 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/04/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are/will be available upon request from Ana Tache (ana.tache@uzbrussel.be). Anonymized radiological imaging and the extraction data table will be available upon request. Access to the charts is forbidden due to privacy law in Belgium. Consent of patients was obtained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/01/2022 | 22/05/2023 | Yes | No |
Editorial Notes
22/05/2023: Publication reference added.
30/03/2022: Trial's existence confirmed by the Institutional Research Ethics Board of Vrije Universiteit Brussel.
