Clinical trial NCT05683509: Alveolar Ridge Preservation With Layered Collagen and Xenograft
Official title: Biologically Oriented Alveolar Ridge Preservation With Layered Collagen and Xenograft (A Randomized Controlled Clinical Trial With Histological Evaluation)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Ridge Preservation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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

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).

Primary outcomes:
measure: Measuring the clinical alveolar ridge changes
timeFrame: at baseline and 4 months
measure: Measuring the radiographic change in the buccal bone thickness
timeFrame: at baseline and 4 months
measure: Measuring the radiographic alveolar ridge dimensional changes
timeFrame: at baseline and 4 months
Secondary outcomes:
measure: Histological assessment of core biopsy
timeFrame: 4 months post operatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Ain Shams University
Study officials:
affiliation: Faculty of dentistry ain shams university
name: Hala Abu el ela, Prof
role: STUDY_CHAIR
References: