Alveolar Ridge Preservation With Layered Collagen and Xenograft

Alveolar Ridge Preservation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05683509
• Other study ID #: PHD-992
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 30, 2022
• Est. completion date: September 2024

Study information

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

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: September 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alveolar Ridge Preservation

Intervention

Procedure:
• deep collagen layer, xenograft and collagen membrane
Alveolar ridge preservation is done using deep collagen layer, xenograft and collagen membrane
• xenograft and collagen membrane
Alveolar ridge preservation is done using xenograft and collagen membrane only

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Ain Shams University	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	Measuring the clinical alveolar ridge changes	Measuring the thickness of the alveolar ridge in mm	at baseline and 4 months
Primary	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
Primary	Measuring the radiographic alveolar ridge dimensional changes	Measuring the bone density in hounsfield units (HU)	at baseline and 4 months
Secondary	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