Alveolar Ridge Preservation with Layered Collagen and Xenograft

Not Applicable

Completed

• Conditions: Alveolar Ridge Preservation
• Interventions: Procedure: deep collagen layer, xenograft and collagen membrane; Procedure: xenograft and collagen membrane

• Registration Number: NCT05683509
• Lead Sponsor: Ain Shams University

Brief Summary

alveolar ridge preservation using deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone. Measuring the clinical and radiographic alveolar ridge dimensional changes following after preservation at the time of implant placement

Detailed Description

alveolar ridge preservation using deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone.

The primary objective of the study is measuring the clinical and radiographic alveolar ridge dimensional changes following the procedure 4 months post operatively

The secondary objective :

* Histological assessment of alveolar bone specimens to assess bone remodeling and new bone formation in both studied groups after four months.

* Patient satisfaction after implant placement

Study Timeline

• Study Start: 2022-05-30
• Study First Submitted: 2022-12-12
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-13
• Primary Completion: 2023-04-30
• Study Completion: 2024-09-01
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Systemically healthy patients (American Society of Anesthesiologists I; ASA I).

  • Patients diagnosed with single unrestorable molar teeth (socket type I) requiring extraction and implant placement (Elian et al.2007).

• Teeth free from any infection or periapical pathosis.

• Enough zone of keratinized tissue with at least 2mm.

• Good compliance with the plaque control instructions following initial therapy.

• Availability for follow up and maintenance program.

Exclusion Criteria

• Bad oral hygiene.
• Presence of smoking habit.
• Presence of occlusal interferences
• Pregnant females
• Vulnerable group of patients (handicapped, mentally retarded and prisoners) (according to the recommendation of esthetical committee of Faculty of Dentistry Ain Shams University).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
deep collagen layer, xenograft and collagen membrane	deep collagen layer, xenograft and collagen membrane	Alveolar ridge preservation is done using deep collagen layer, xenograft and collagen membrane
xenograft and collagen membrane	xenograft and collagen membrane	Alveolar ridge preservation is done using xenograft and collagen membrane alone

Primary Outcome Measures

Name	Time	Method
Measuring the clinical alveolar ridge changes	at baseline and 4 months	Measuring the thickness of the alveolar ridge in mm
Measuring the radiographic change in the buccal bone thickness	at baseline and 4 months	Measuring the change in the thickness of the buccal ridge radiographically in mm
Measuring the radiographic alveolar ridge dimensional changes	at baseline and 4 months	Measuring the bone density in hounsfield units (HU)

Secondary Outcome Measures

Name	Time	Method
Histological assessment of core biopsy	4 months post operatively	The microscopic examination of the bone remodeling and new bone through tissue biopsy (fixation and staining of the tissues) to examine the newly formed cells and count them to determine the amount of newly tissue formed

Trial Locations

Locations (1)

Faculty of Dentistry Ain Shams University; 🇪🇬 Cairo, Egypt