Alveolar Ridge Preservation With Layered Collagen and Xenograft

NCT ID: NCT05683509

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-30

Study Completion Date

2024-09-01

Brief Summary

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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

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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

Conditions

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Alveolar Ridge Preservation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
the outcome assessor will be blinded about the grouping and which patient got which treatment

Study Groups

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deep collagen layer, xenograft and collagen membrane

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

Group Type ACTIVE_COMPARATOR

deep collagen layer, xenograft and collagen membrane

Intervention Type PROCEDURE

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 alone

Group Type ACTIVE_COMPARATOR

xenograft and collagen membrane

Intervention Type PROCEDURE

Alveolar ridge preservation is done using xenograft and collagen membrane only

Interventions

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deep collagen layer, xenograft and collagen membrane

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

Intervention Type PROCEDURE

xenograft and collagen membrane

Alveolar ridge preservation is done using xenograft and collagen membrane only

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hala Abu el ela, Prof

Role: STUDY_CHAIR

Faculty of dentistry ain shams university

Locations

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Faculty of Dentistry Ain Shams University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PHD-992

Identifier Type: -

Identifier Source: org_study_id

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