Alveolar Ridge Preservation With Layered Collagen and Xenograft

NCT05683509 | Completed

• 1 other identifier: PHD-992
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Alveolar Ridge Preservation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Histological assessment of core biopsy

  4 months post operatively

Study Arms (2)

deep collagen layer, xenograft and collagen membrane

ACTIVE COMPARATOR

Alveolar ridge preservation is done using deep collagen layer, xenograft and collagen membrane

Procedure: deep collagen layer, xenograft and collagen membrane

xenograft and collagen membrane

ACTIVE COMPARATOR

Alveolar ridge preservation is done using xenograft and collagen membrane alone

Procedure: xenograft and collagen membrane

Interventions

deep collagen layer, xenograft and collagen membrane PROCEDURE

Alveolar ridge preservation is done using deep collagen layer, xenograft and collagen membrane

deep collagen layer, xenograft and collagen membrane

xenograft and collagen membrane PROCEDURE

Alveolar ridge preservation is done using xenograft and collagen membrane only

xenograft and collagen membrane

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, Cairo Governorate, 4393005, Egypt

Location

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Hala Abu el ela, Prof

  Faculty of dentistry ain shams university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the outcome assessor will be blinded about the grouping and which patient got which treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The application of deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone in alveolar ridge preservation procedures.

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 13, 2023
• Study Start: May 30, 2022
• Primary Completion: April 30, 2023
• Study Completion: September 1, 2024
• Last Updated: February 24, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)