Polynucleotide-Hyaluronic Acid Gel With Xenograft for Alveolar Ridge Preservation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCairo University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Polynucleotide-Hyaluronic Acid Gel With Xenograft

    Other intervention

    Xenograft mixed with polynucleotide-hyaluronic acid gel and covered with a collagen membrane for alveolar ridge preservation after tooth extraction.

  • Xenograft With Collagen Membrane

    Other intervention

    Xenograft placed in the extraction socket and covered with a collagen membrane for alveolar ridge preservation after tooth extraction.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Polynucleotide-Hyaluronic Acid Gel With XenograftExperimental treatment 1 intervention
Group B: Xenograft AloneActive comparator 1 intervention

Trial outcomes

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

Time frame
Baseline and 6 months

Secondary outcomes

1

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.

Time frame
Baseline and 6 months
2

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.

Time frame
Baseline and 6 months
3

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.

Time frame
6 months
4

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

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