NCT07338136

Brief Summary

  • Full thickness Buccal bone lid approach is well known and well reported technique with a superiority on preserving bone volume and better bone healing especially when done using piezoelectrical devices when compared to conventional technique for management of mandibular pathosis, however periosteum disturbance have a negative role regarding vascularity and bone healing, by comparing the split thickness VS full thickness flap design with buccal bone lid approach, this study will highlight if the periosteum preserved attached to the lid improve the healing on mandibular bony pathosis.
  • Aim of the study: determine the effect of split thickness flap vs full thickness flap using a guided bone lid in hard mandibular pathosis in term of bone healing.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Feb 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Feb 2026Apr 2027

First Submitted

Initial submission to the registry

January 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 3, 2026

Last Update Submit

January 13, 2026

Conditions

Keywords

buccal bone lidsplit thickness flapcomputer guided surgerymandibular pathosisimpacted tooth

Outcome Measures

Primary Outcomes (1)

  • • bone defect filling

    bone healing will be measured with Cone beam CT

    6 months

Secondary Outcomes (3)

  • • Intra-operative time

    intra operative time needed for both techniques

  • • Pain

    first , third . 7th day post operative

  • • Accuracy of transfer of the cutting guide

    immediate post operative using the post operative CBCT

Study Arms (2)

computer guided full thickness flap for buccal bone lid approuch in hard mandibular pathosis

ACTIVE COMPARATOR

* After anaesthesia administration, a full-thickness flap will be elevated with one or two releasing incisions. * Guide will be seated according to the pre-planned position. * The bone lid osteotomies will be prepared following the internal profile of the guide using a piezoelectrical device. * The guide will be removed, and the bone lid will be completed and detached. * The bony lid will be saved in saline solution until fixation. * Pathosis will be removed completely, and the lid will be returned and fixed to its original position using one or more screw. * Suturing with primary closure will be obtained. * Immediate post-operative CBCT will be taken

Procedure: computer guided split thickness flap for buccal bone lid approuch

computer guided split thickness flap for buccal bone lid approuch in hard mandibular pathosis

EXPERIMENTAL

* After anesthesia administration, a split-thickness flap will be elevated. * Guide will be seated according to the pre-planned position. * Periosteal incision will be performed following the external profile of the surgical guide. * The guide will be removed, and a minimum periosteal reflection will be done. * The guide will be placed again, and the bone lid osteotomies will be prepared following the internal profile of the guide using piezoelectrical device. * The guide will be removed again, and the bone lid will be completed and detached with its attached periosteum. * The bony lid with its attached periosteum will be saved in saline solution until fixation. * Pathosis will be removed completely, and the lid will be returned and fixed to its original position using one or more screw. * Suturing with primary closure will be obtained.

Procedure: computer guided split thickness flap for buccal bone lid approuch

Interventions

* After anesthesia administration, a split thickness flap will be elevated. * Guide will be seated according to the pre-planned position. * Periosteal incision will be performed following the external profile of the surgical guide. * The guide will be removed and minimum periosteal reflection will be done. * The guide will be placed again and the bone lid osteotomies will be prepared following the internal profile of the guide using piezoelectrical device. * The guide will be removed again, and the bone lid will be completed and detached with its attached periosteum. * The bony lid with its attached periosteum will be saved in saline solution until fixation. * Pathosis will be removed completely, and the lid will be returned and fixed to its original position using one or more screw. * Suturing with primary closure will be obtained. * Immediate post-operative CBCT will be taken

computer guided full thickness flap for buccal bone lid approuch in hard mandibular pathosiscomputer guided split thickness flap for buccal bone lid approuch in hard mandibular pathosis

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • No sex predilection.
  • Age: 18 to 40
  • mandibular intra-bony hard pathosis with a diameter ≥1cm with a buccal cortex thickness ≥1mm

You may not qualify if:

  • Systemic or local disease/ condition that could affect bone healing
  • Diabetics
  • patients on systemic corticosteroid
  • chemotherapy
  • radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Sivolella S, Brunello G, Panda S, Schiavon L, Khoury F, Del Fabbro M. The Bone Lid Technique in Oral and Maxillofacial Surgery: A Scoping Review. J Clin Med. 2022 Jun 24;11(13):3667. doi: 10.3390/jcm11133667.

    PMID: 35806950BACKGROUND
  • Mounir M, Beheiri G, El-Beialy W. Assessment of marginal bone loss using full thickness versus partial thickness flaps for alveolar ridge splitting and immediate implant placement in the anterior maxilla. Int J Oral Maxillofac Surg. 2014 Nov;43(11):1373-80. doi: 10.1016/j.ijom.2014.05.021. Epub 2014 Jun 25.

    PMID: 24973295BACKGROUND
  • Khoury F, Hanser T. Mandibular bone block harvesting from the retromolar region: a 10-year prospective clinical study. Int J Oral Maxillofac Implants. 2015 May-Jun;30(3):688-97. doi: 10.11607/jomi.4117.

    PMID: 26009921BACKGROUND
  • Gamal AY, Mailhot JM. A novel marginal periosteal pedicle graft as an autogenous guided tissue membrane for the treatment of intrabony periodontal defects. J Int Acad Periodontol. 2008 Oct;10(4):106-17.

    PMID: 19055224BACKGROUND
  • Fickl S, Kebschull M, Schupbach P, Zuhr O, Schlagenhauf U, Hurzeler MB. Bone loss after full-thickness and partial-thickness flap elevation. J Clin Periodontol. 2011 Feb;38(2):157-62. doi: 10.1111/j.1600-051X.2010.01658.x. Epub 2010 Nov 30.

    PMID: 21118288BACKGROUND
  • Degerliyurt K, Akar V, Denizci S, Yucel E. Bone lid technique with piezosurgery to preserve inferior alveolar nerve. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Dec;108(6):e1-5. doi: 10.1016/j.tripleo.2009.08.006.

    PMID: 19913713BACKGROUND
  • Debnath S, Yallowitz AR, McCormick J, Lalani S, Zhang T, Xu R, Li N, Liu Y, Yang YS, Eiseman M, Shim JH, Hameed M, Healey JH, Bostrom MP, Landau DA, Greenblatt MB. Discovery of a periosteal stem cell mediating intramembranous bone formation. Nature. 2018 Oct;562(7725):133-139. doi: 10.1038/s41586-018-0554-8. Epub 2018 Sep 24.

    PMID: 30250253BACKGROUND
  • Abu Hawa MH, Shehri Z, Alkhouri I. Comparison Between the Bone Lid Technique and the Traditional Technique in Surgical Treatment of the Posterior Mandibular Lesions: A Randomized Controlled Trial. Cureus. 2022 Jun 22;14(6):e26223. doi: 10.7759/cureus.26223. eCollection 2022 Jun.

    PMID: 35911276BACKGROUND

MeSH Terms

Conditions

Mandibular DiseasesTooth, Impacted

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesTooth Diseases

Central Study Contacts

Ahmed M. Salah Azab, bachelor degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

January 3, 2026

First Posted

January 13, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share