Effect of Advanced PRF and Hyaluronic Acid on Dental Implant Healing

NCT07792720 | Recruiting

• 1 other identifier: OMFS-033\06\2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized parallel-group clinical trial aimed to evaluate the clinical efficacy of advanced platelet-rich fibrin (A-PRF) combined with hyaluronic acid (HA) in enhancing peri-implant bone formation in patients undergoing delayed dental implant placement. Participants will be allocated to either a test group, in which A-PRF combined with HA is applied at the implant site, or a control group receiving conventional implant placement without adjunctive biomaterials. Peri-implant bone changes will be assessed using cone-beam computed tomography (CBCT), including radiographic bone density and bone volume measurements. Implant stability will also be evaluated using resonance frequency analysis at the time of implant placement and during follow-up. Additional clinical outcomes include postoperative pain and implant survival. The participants will be followed up for six months after implant placement.

Conditions

Partial Edentulism; Dental Implant Placement

Keywords

Dental Implant Placement; Advanced Platelet-Rich Fibrin; A-PRF; Hyaluronic Acid; Osseointegration; Implant Stability; Cone-Beam Computed Tomography; Peri-Implant Bone; Bone Formation

Outcome Measures

Primary Outcomes (2)

• CBCT-Derived Peri-Implant Bone Volume

  The peri-implant bone volume will be assessed using cone-beam computed tomography (CBCT) at baseline and 6 months after dental implant placement. Changes in bone volume between baseline and the 6-month follow-up will be evaluated and compared between the test and control groups.

  Baseline and 6 months after implant placement

• CBCT-Derived Peri-Implant Radiographic Density

  Peri-implant radiographic density will be assessed using cone-beam computed tomography (CBCT) at baseline and 6 months after dental implant placement. Changes in radiographic density between baseline and the 6-month follow-up will be evaluated and compared between the test and control groups.

  Baseline and 6 months after implant placement

Secondary Outcomes (2)

• Implant Stability Quotient (ISQ)

  At implant placement and 6 months after implant placement

• Implant Survival

  Up to 6 months after implant placement

Study Arms (2)

Test Group

EXPERIMENTAL

Participants receive delayed dental implant placement with adjunctive application of advanced platelet-rich fibrin (A-PRF) combined with hyaluronic acid at the implant site.

Procedure: Delayed Dental Implant Placement; Procedure: Advanced Platelet-Rich Fibrin (A-PRF); Device: Hyaluronic Acid 1.5%

Control Group

ACTIVE COMPARATOR

Participants receive delayed dental implant placement without adjunctive A-PRF or hyaluronic acid.

Procedure: Delayed Dental Implant Placement

Interventions

Delayed Dental Implant Placement PROCEDURE

A dental implant was surgically placed into a healed edentulous site using a standardized delayed-placement protocol. This procedure was performed in both the test and control groups.

Control Group; Test Group

Advanced Platelet-Rich Fibrin (A-PRF) PROCEDURE

Autologous advanced platelet-rich fibrin (A-PRF) was prepared from the participants' venous blood using a standardized centrifugation protocol and applied at the dental implant site. In the test group, A-PRF was used in combination with hyaluronic acid as an adjunct to delayed dental implant placement.

Test Group

Hyaluronic Acid 1.5% DEVICE

In the test group, 1.5% hyaluronic acid is combined with autologous advanced platelet-rich fibrin (A-PRF) and applied locally at the dental implant site during delayed dental implant placement. The control group does not receive hyaluronic acid.

Test Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adults aged 18-65 years.
• Patients requiring delayed dental implant placement in a posterior mandibular edentulous site
• Sufficient residual alveolar bone height and width to permit conventional implant placement without the need for simultaneous guided bone regeneration (GBR), ridge augmentation, or other bone-grafting procedures.
• Good general health or a medically controlled and stable systemic condition compatible with elective implant surgery and not expected to materially compromise wound or bone healing.
• Non-smokers with no current use of tobacco products.
• Acceptable oral hygiene and a periodontal condition compatible with implant surgery following any required professional treatment and reassessment.
• Ability and willingness to undergo the required clinical and radiographic assessments, including CBCT examinations at baseline and at the 6-month follow-up.
• Ability and willingness to attend the scheduled follow-up visits and comply with the study procedures.
• Provision of written informed consent before study participation.

You may not qualify if:

• Any uncontrolled systemic disease or medical condition that conensions for conventional implant placement without augmentation.
• Requirement for immediate implant placement, simultaneous guided bone regeneration, ridge augmentation, or any other adjunctive bone-grafting procedure.
• Inability or unwillingness to complete the required 6-month clinical and radiographic follow-up.traindicates elective implant surgery or may substantially impair wound or bone healing, including uncontrolled diabetes mellitus.
• Immunocompromised status or current systemic immunosuppressive therapy.
• Current or previous use of oral or parenteral bisphosphonates or other antiresorptive medications associated with a risk of medication-related osteonecrosis of the jaw.
• Pregnancy at the time of screening or enrollment.
• Unresolved active periodontal disease or active local infection involving the intended implant site, including suppuration.
• Inadequate oral hygiene that persists after professional oral-hygiene instruction, necessary periodontal treatment, and reassessment.
• Insufficient residual alveolar bone dim

Sponsors & Collaborators

• Samar Ali Abdu Salamah: lead

Study Sites (1)

Beauty Smile Dental Center

Sanaa, Sana'a, Yemen

RECRUITING

Study Officials

• Samar A salamah, BDS

  Sana'a University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samar A Salamah, BDS

CONTACT

+967777277949; samarali777277949@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The CBCT outcome assessor will be blinded to participant group allocation. CBCT images will be coded before assessment so that the assessor cannot identify whether participants belong to the test or control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master's Candidate in Oral and Maxillofacial Surgery

Model Details: Participants are randomized to either the test group, receiving A-PRF combined with hyaluronic acid during dental implant placement, or the control group, receiving conventional dental implant placement.

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start: June 5, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

YE (1)