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Clinical Trials/NCT05683509
NCT05683509
Completed
Not Applicable

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

Ain Shams University1 site in 1 country20 target enrollmentMay 30, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alveolar Ridge Preservation
Sponsor
Ain Shams University
Enrollment
20
Locations
1
Primary Endpoint
Measuring the clinical alveolar ridge changes
Status
Completed
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
May 30, 2022
End Date
September 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Measuring the clinical alveolar ridge changes

Time Frame: at baseline and 4 months

Measuring the thickness of the alveolar ridge in mm

Measuring the radiographic change in the buccal bone thickness

Time Frame: 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

Time Frame: at baseline and 4 months

Measuring the bone density in hounsfield units (HU)

Secondary Outcomes

  • Histological assessment of core biopsy(4 months post operatively)

Study Sites (1)

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