Clinical trial NCT06523855: Evaluation of Bilateral Alveolar Cleft Grafting With Micro Plate Stabilization Versus Conventional Grafting Technique
Official title: Clinical and Radiographic Evaluation of Bilateral Alveolar Cleft Grafting With Micro Plate Stabilization Versus Conventional Grafting Technique: A Preliminary Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alveolar Cleft
Keywords: alveolar cleft
iliac crest grafting
microplate
bone resorption
oronasal fistula
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 12
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to enhance the maxillary segments stability during graft healing using microplate fixation to be compared with conventional grafting technique regarding gained bone quality and quantity.

Detailed description: In conventional cleft grafting technique, there is always risk for grafted bone resorption and recurrence of fistula formation. So alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments will work more efficient and prevent the fore mentioned risk of graft resorption and recurrence of fistula.

In conventional cleft grafting techniques, most of the cases reported in literature raised a debate regarding the final gained amount of bone, with subsequent recurrence of oronasal fistula. In this study, alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments and the conventional grafting technique will be compared to evaluate which technique will offer better reconstruction of the alveolar ridge with maintained bone width and height.

Eligibility criteria: Inclusion Criteria:

* Patients with bilateral complete maxillary alveolar cleft at the age of mixed dentition (between 9 and 12 years old).
* repaired cleft lip.
* Patients with medical history that did not hinder surgical intervention and have adequate proper oral hygiene.
* Both genders males and females will be included.

Exclusion Criteria:

* General contraindications to surgical intervention of the area.
* Patients with unilateral maxillary alveolar cleft.
* Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft
* Subjected to irradiation in the head and neck area less than 1 year before surgery.
* Untreated periodontitis.
* Poor oral hygiene.
* Uncontrolled diabetes.
* Immunosuppressed or immunocompromised.
* Active infection or severe inflammation in the area intended for graft placement
* Unable to open mouth sufficiently to accommodate the surgical tooling.
* Patients participating in other studies, if the present protocol could not be properly followed.
* Unable to attend a 9-month follow-up.

Primary outcomes:
measure: Bone density immediate versus 6 months postoperatively.
timeFrame: 6 months
Secondary outcomes:
measure: Bone width and height immediate versus 6 months postoperatively
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo university
Study officials:
affiliation: Cairo University
name: Sameh Mekhemer, PhD
role: STUDY_DIRECTOR
References:
citation: Smarius B, Loozen C, Manten W, Bekker M, Pistorius L, Breugem C. Accurate diagnosis of prenatal cleft lip/palate by understanding the embryology. World J Methodol. 2017 Sep 26;7(3):93-100. doi: 10.5662/wjm.v7.i3.93. eCollection 2017 Sep 26.
citation: Seifeldin SA. Is alveolar cleft reconstruction still controversial? (Review of literature). Saudi Dent J. 2016 Jan;28(1):3-11. doi: 10.1016/j.sdentj.2015.01.006. Epub 2015 Jun 25.
citation: Mahardawi B, Boonsiriseth K, Pairuchvej V, Wongsirichat N. Alveolar cleft bone grafting: factors affecting case prognosis. J Korean Assoc Oral Maxillofac Surg. 2020 Dec 31;46(6):409-416. doi: 10.5125/jkaoms.2020.46.6.409.
citation: Boyne PJ, Sands NR. Secondary bone grafting of residual alveolar and palatal clefts. J Oral Surg. 1972 Feb;30(2):87-92. No abstract available.
citation: Chen S, Liu B, Liu J, Yin N, Wang Y. Comparison of Three-Dimensional Printing and Computer-aided Engineering in Presurgical Volumetric Assessment of Bilateral Alveolar Clefts. J Craniofac Surg. 2020 Mar/Apr;31(2):412-415. doi: 10.1097/SCS.0000000000006011.