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

NCT ID: NCT06139939

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2023-08-30

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.

Conditions

Guided Bone Regeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Double layer technique

Intervention Type: PROCEDURE

Double layer technique for alveolar ridge augmentation (first layer autograft followed by xenograft second layer).

control

include 9 patients will receive lateral alveolar ridge augmentation with stander protocol for GBR technique (mixture of autograft and xenograft

Group Type: OTHER

Double layer technique

Intervention Type: PROCEDURE

Double layer technique for alveolar ridge augmentation (first layer autograft followed by xenograft second layer).

Interventions

Double layer technique

Double layer technique for alveolar ridge augmentation (first layer autograft followed by xenograft second layer).

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Leila Elraee Ibrahim

assistant lecture

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain shams university , faculty of dentistry

Cairo, , Egypt

Countries

Egypt

Other Identifiers

112

Identifier Type: -

Identifier Source: org_study_id