Alveolar Ridge Preservation With Layered Collagen and Xenograft

Biologically Oriented Alveolar Ridge Preservation With Layered Collagen and Xenograft (A Randomized Controlled Clinical Trial With Histological Evaluation)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Alveolar Ridge Preservation
• Intervention / Treatment: Procedure: deep collagen layer, xenograft and collagen membrane; Procedure: xenograft and collagen membrane

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 4393005
    • Faculty of Dentistry Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: deep collagen layer, xenograft and collagen membrane; Alveolar ridge preservation is done using deep collagen layer, xenograft and collagen membrane	Procedure: deep collagen layer, xenograft and collagen membrane; Alveolar ridge preservation is done using deep collagen layer, xenograft and collagen membrane
Active Comparator: xenograft and collagen membrane; Alveolar ridge preservation is done using xenograft and collagen membrane alone	Procedure: xenograft and collagen membrane; Alveolar ridge preservation is done using xenograft and collagen membrane only

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological assessment of core biopsy	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	4 months post operatively

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Hala Abu el ela, Prof, Faculty of Dentistry Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PHD-992

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No