Guided Bone Regeneration for Horizontal Alveolar Ridge Augmentation With Double Layer Technique

Not Applicable

Completed

• Conditions: Guided Bone Regeneration
• Interventions: Procedure: Double layer technique

• Registration Number: NCT06139939
• Lead Sponsor: Ain Shams University

Brief Summary

clinical study with guided bone regeneration for deficient alveolar ridge to restore the defect in width and be able to place implant with two different technique

Detailed Description

This study will be conducted to compare the bone formation with double layer graft technique versus standard protocol in GBR for horizontal ridge augmentation with staged implant placement

Primary outcome: Evaluation of alveolar bone width gain clinically and radiographically.

Secondary outcome: Histological analysis of remodeled bone.

Study Timeline

• Study Start: 2021-05-06
• Primary Completion: 2023-05-30
• Study Completion: 2023-08-30
• Status Verified: 2023-11
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• 1- Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire. (American Society of Anesthesiologists I; ASA I) (Mombelli and Cionca, 2006) 2- Both genders. 3- Age from 20 - 40 years old. 4- Having missing maxillary or mandibular tooth with low or moderate horizontal defect (4-8) according to cologne classification (2013) 5- Presence of sufficient bone height minimum 12 mm that does not require bone grafting or any other ridge augmentation procedure.(Shah and Lum, 2008) 6- Presence of sufficient keratinized mucosa of at least 2 mm.(Bassetti, et al. 2015)

Exclusion Criteria

• 1- Smokers (Twito and Sade, 2014) 2- Vulnerable groups (as pregnant females and decisional impaired individuals) will be excluded from the study.

  3- Patients with poor oral hygiene or not willing to perform oral hygiene measures.

  4- Prisoners and handicapped patients. 5- Patients with periodontal or periapical infections.(Tonetti, et al. 1996)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
double layer technique	Double layer technique	include 9 patients will receive lateral alveolar ridge augmentation with double bone graft layer technique for GBR (first layer autograft followed by xenograft second layer
control	Double layer technique	include 9 patients will receive lateral alveolar ridge augmentation with stander protocol for GBR technique (mixture of autograft and xenograft

Primary Outcome Measures

Name	Time	Method
clinical and radiographic outcome	6 months	clinical ridge width gain

Secondary Outcome Measures

Name	Time	Method
histological analysis of remodeled bone.	6 months	core biopsy were taken after 6 months from augmentation

Trial Locations

Locations (1)

Ain shams university , faculty of dentistry; 🇪🇬 Cairo, Egypt