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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05683509
Other study ID # PHD-992
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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