Alveolar Ridge Preservation
Conditions
Keywords
Socket Preservation, Alveolar Ridge Preservation, Polynucleotide, Hyaluronic Acid, Xenograft, Collagen Membrane
Brief summary
This randomized controlled clinical trial will evaluate the efficacy of polynucleotide-hyaluronic acid gel combined with xenograft and collagen membrane for alveolar ridge preservation following tooth extraction. Twenty participants will be randomly allocated into two parallel groups. The test group will receive xenograft mixed with polynucleotide-hyaluronic acid gel and covered with a collagen membrane, while the control group will receive xenograft with a collagen membrane alone. Clinical and CBCT assessments will be performed at baseline and during follow-up. After 6 months, ridge dimensional changes will be evaluated and core biopsies will be obtained at the time of implant placement for histological assessment.
Interventions
OTHERPolynucleotide-Hyaluronic Acid Gel With Xenograft
Xenograft mixed with polynucleotide-hyaluronic acid gel and covered with a collagen membrane for alveolar ridge preservation after tooth extraction.
OTHERXenograft With Collagen Membrane
Xenograft placed in the extraction socket and covered with a collagen membrane for alveolar ridge preservation after tooth extraction.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor and biostatistician will be blinded to group allocation. Blinding of the operator is not applicable.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18-60 years. * Patients free from systemic diseases affecting wound healing or bone regeneration or contraindicating oral surgery. * Non-smokers with good oral hygiene. * Patients requiring tooth extraction in non-infected sockets due to endodontic failure, non-restorable caries, or trauma, and who will receive implant treatment. * Class I extraction sockets with intact alveolar bone walls. * Presence of teeth adjacent to the extraction site.
Exclusion criteria
* Use of drugs affecting wound healing. * Heavy smokers (\>10 cigarettes/day) or history of substance abuse. * Pregnant or breastfeeding women. * Previous grafting or surgical intervention in the study area. * Uncontrolled and/or untreated periodontal disease (active periodontitis). * Mentally or physically handicapped patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Buccal Bone Plate Height | Baseline and 6 months | The height of the buccal bone plate will be measured using digital superimposition of Cone Beam Computed Tomography (CBCT) scans obtained at baseline and 6 months. Measurements will be recorded in millimeters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Palatal Bone Plate Height | Baseline and 6 months | The height of the palatal bone plate will be measured using digital superimposition of Cone Beam Computed Tomography (CBCT) scans obtained at baseline and 6 months. Measurements will be recorded in millimeters. |
| Change in Horizontal Ridge Width | Baseline and 6 months | Horizontal ridge width will be measured using digital superimposition of Cone Beam Computed Tomography (CBCT) scans at 2 mm, 4 mm, and 6 mm below the most coronal aspect of the alveolar crest. Measurements will be compared between baseline and 6 months and recorded in millimeters. |
| Percentage of New Vital Bone Formation | 6 months | The percentage of newly formed vital bone will be assessed histologically and histomorphometrically in core biopsy specimens obtained from the preserved site at the time of implant placement after 6 months. |
| Percentage of Residual Graft Particles | 6 months | The percentage of residual graft particles will be assessed histologically and histomorphometrically in core biopsy specimens obtained from the preserved site at the time of implant placement after 6 months. |
Countries
Egypt
Contacts
CONTACTMaryam Alabbas, BDS
PRINCIPAL_INVESTIGATORMaryam Alabbas, BDS
Cairo University
STUDY_CHAIRManal Hosni
Cairo University
Outcome results
None listed