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

July 5, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Hillah, Babylon, Iraq
        • Private specialized dental center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 2, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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