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

Guided Bone Regeneration Clinical Trial

Official title:

Evaluation of Double Layer Graft Technique for Horizontal Ridge Augmentation With Staged Implant Placement (A Randomized Controlled Clinical Trial With Histological Assessment)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06139939
• Other study ID #: 112
• Status: Completed
• Phase: N/A
• Start date: May 6, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: November 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Guided Bone Regeneration

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain shams university , faculty of dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical and radiographic outcome	clinical ridge width gain	6 months
Secondary	histological analysis of remodeled bone.	core biopsy were taken after 6 months from augmentation	6 months