NCT07771257

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

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress16%
Sep 2026Apr 2027

First Submitted

Initial submission to the registry

August 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

August 18, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 13, 2026

Last Update Submit

August 13, 2026

Conditions

Keywords

Socket PreservationAlveolar Ridge PreservationPolynucleotideHyaluronic AcidXenograftCollagen Membrane

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

EXPERIMENTAL

Alveolar ridge preservation using xenograft mixed with polynucleotide-hyaluronic acid gel and covered with a collagen membrane.

Other: Polynucleotide-Hyaluronic Acid Gel With Xenograft

Xenograft Alone

ACTIVE COMPARATOR

Alveolar ridge preservation using xenograft covered with a collagen membrane.

Other: Xenograft With Collagen Membrane

Interventions

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

Polynucleotide-Hyaluronic Acid Gel With Xenograft

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

Xenograft Alone

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Officials

  • Maryam Alabbas, BDS

    Cairo University

    PRINCIPAL INVESTIGATOR
  • Manal Hosni

    Cairo University

    STUDY CHAIR

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.

Locations