Polynucleotide-Hyaluronic Acid Gel With Xenograft for Alveolar Ridge Preservation
Evaluation of the Efficacy of Polynucleotide-Hyaluronic Acid Gel With Xenograft Compared to Xenograft Alone in Alveolar Ridge Preservation: A Randomized Clinical Trial
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2026
CompletedFirst Posted
Study publicly available on registry
August 18, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
August 18, 2026
August 1, 2026
7 months
August 13, 2026
August 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Buccal Bone Plate Height
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
Baseline and 6 months
Secondary Outcomes (4)
Change in Palatal Bone Plate Height
Baseline and 6 months
Change in Horizontal Ridge Width
Baseline and 6 months
Percentage of New Vital Bone Formation
6 months
Percentage of Residual Graft Particles
6 months
Study Arms (2)
Polynucleotide-Hyaluronic Acid Gel With Xenograft
EXPERIMENTALAlveolar ridge preservation using xenograft mixed with polynucleotide-hyaluronic acid gel and covered with a collagen membrane.
Xenograft Alone
ACTIVE COMPARATORAlveolar ridge preservation using xenograft covered with a collagen membrane.
Interventions
Xenograft mixed with polynucleotide-hyaluronic acid gel and covered with a collagen membrane for alveolar ridge preservation after tooth extraction.
Xenograft placed in the extraction socket and covered with a collagen membrane for alveolar ridge preservation after tooth extraction.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maryam Alabbas, BDS
Cairo University
- STUDY CHAIR
Manal Hosni
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcome assessor and biostatistician will be blinded to group allocation. Blinding of the operator is not applicable.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master's Student in Periodontology
Study Record Dates
First Submitted
August 13, 2026
First Posted
August 18, 2026
Study Start
September 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
August 18, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared outside the study research team in order to maintain participant confidentiality and data protection.