About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Polynucleotide-Hyaluronic Acid Gel With Xenograft
Other interventionXenograft mixed with polynucleotide-hyaluronic acid gel and covered with a collagen membrane for alveolar ridge preservation after tooth extraction.
Xenograft With Collagen Membrane
Other interventionXenograft placed in the extraction socket and covered with a collagen membrane for alveolar ridge preservation after tooth extraction.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Change in Palatal Bone Plate Height
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
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
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
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.
Sponsors and contacts
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