Impact of Hyaluronic Acid and Bone Graft on Peri-Implant Tissue

June 23, 2026 updated by: Monya Noori Hassan, Al-Mustansiriyah University

Impact of Hyaluronic Acid and Bone Graft on PeriImplant Tissue Phenotype."A Randomized Controlled Trial"

This randomized controlled clinical trial aims to evaluate the effect of hyaluronic acid (HA) and particulate bone graft on the peri-implant tissue phenotype in patients receiving dental implants. Healthy adult participants requiring dental implant placement will be randomly allocated into one of three equal groups (12 implants per group): Group 1 will receive dental implants combined with hyaluronic acid gel (Gengigel); Group 2 will receive dental implants combined with both hyaluronic acid and particulate bone graft; and the control group will receive dental implants alone.

Clinical and radiographic assessments will be performed using a customized measurement stent to ensure standardized evaluations at baseline, immediately postoperatively, and at 8 and 16 weeks of follow-up. The primary and secondary outcomes include alterations in ridge width, keratinized tissue width/thickness, radiographic soft tissue height, and marginal bone height. The study aims to determine whether the adjunctive use of hyaluronic acid and bone grafts enhances the quality of the peri-implant soft and hard tissue phenotype.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • Babylon
      • Hillah, Babylon, Iraq
        • College of Dentistry, University of Babylon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults ≥ 18 years old.
  • Partially edentulous patients requiring dental implant placement.
  • Good oral hygiene (Calibrated Gingival Bleeding Index (GBI) < 10%, O'Leary ---Plaque Index (PI) < 10%).
  • Sufficient bone volume for implant placement.

Exclusion Criteria:

  • Systemic conditions affecting bone healing (e.g., uncontrolled diabetes).
  • Smoking > 10 cigarettes/day.
  • Medications affecting bone metabolism (e.g., bisphosphonates).
  • Active periodontal disease.
  • Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Dental Implants + Hyaluronic Acid
Patients receive dental implants combined with hyaluronic acid gel applied at the implant site.
Procedure: Dental Implants with Hyaluronic Acid
Surgical placement of dental implants, followed by the application of hyaluronic acid gel at the implant site, was performed to evaluate its impact on peri-implant tissue phenotype.
Experimental: Group 2: Dental Implants + Hyaluronic Acid + Bone Graft
Patients receive dental implants combined with hyaluronic acid gel and particulate bone graft applied at the implant site.
Procedure: Dental Implants with Hyaluronic Acid and Particulate Bone Graft
Surgical placement of dental implants, combined with the application of hyaluronic acid gel and particulate bone graft at the implant site, was performed to evaluate its impact on peri-implant tissue phenotype.
Active Comparator: Group 3: Control Group: Dental Implants Alone
Patients receive standard dental implants placement alone without any adjunctive materials.
Procedure: Standard Dental Implants Placement only
Standard surgical placement of dental implants following conventional clinical protocols without the application of any adjunctive materials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ridge Width Changes (RW)
Time Frame: Baseline (preoperative), immediate postoperative, 8 weeks, and 16 weeks.
The changes in Ridge Width is measured at the reference points using a digital vernier caliper.
Baseline (preoperative), immediate postoperative, 8 weeks, and 16 weeks.
Bone Width (BW)
Time Frame: Baseline (preoperative), and 16 weeks postoperatively
Measured in millimeters by subtracting the buccal and lingual mucosal thickness from the ridge width.
Baseline (preoperative), and 16 weeks postoperatively
Change in width of keratinized tissue (KTW)
Time Frame: Baseline (preoperative), 8 weeks, and 16 weeks
Measured in millimeters at the mid-buccal aspect of the implant site using an endodontic rotary file and digital vernier caliper.
Baseline (preoperative), 8 weeks, and 16 weeks
Keratinized Tissue Thickness (KTT)
Time Frame: Baseline (preoperative), and 16 weeks postoperatively
Measured in millimeters at the buccal, crestal and lingual reference points using a periodontal probe and a digital vernier caliper.
Baseline (preoperative), and 16 weeks postoperatively
Radiographic Mucosal Thickness (RT)
Time Frame: Baseline (preoperative), immediate postoperative, 8 weeks, and 16 weeks
Measured in millimeters on periapical radiographs using digital software from the crestal bone level to the crest of crestal oral mucosa 5 mm away from the height distal surface of the adjacent tooth on the mesial side of the implant.
Baseline (preoperative), immediate postoperative, 8 weeks, and 16 weeks
Crestal Bone Height (BH)
Time Frame: Immediate postoperative, 8 weeks, and 16 weeks
Measured in millimeters on periapical radiographs using digital software from the second serration on the mesial side of the implant to the crest of the bone.
Immediate postoperative, 8 weeks, and 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index (PI)
Time Frame: Baseline (preoperative), 8 weeks, and 16 weeks
O'Leary plaque index
Baseline (preoperative), 8 weeks, and 16 weeks
Gingival Index (GI)
Time Frame: Baseline (preoperative), 8 weeks, and 16 weeks
Gingival Bleeding Index
Baseline (preoperative), 8 weeks, and 16 weeks
Postoperative Pain Scores
Time Frame: Three times daily (morning, afternoon, and evening) for the first 7 days postoperatively
Patients received a standardized pain assessment chart for self-evaluation over seven consecutive postoperative days. This chart featured an 11-point (0-10) Numerical Rating Scale (NRS) integrated with the Wong-Baker Faces Pain Rating Scale and supplemented with descriptive pain expressions ranging from a minimum value of 0 (representing no pain) to a maximum value of 10 (representing the worst possible pain), where higher scores indicate a worse outcome (greater pain severity).
Three times daily (morning, afternoon, and evening) for the first 7 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Mustansiriyah University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 18, 2026

First Submitted That Met QC Criteria

June 18, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUOSU/POST-202615

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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