Skip to main content
OpenTrials
Completed

NCT Number: NCT07665281

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alveolar Bone Loss Bone Diseases Bone Resorption Dental Implant Jaw Diseases Jaw, Edentulous Jaw, Edentulous, Partially Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Partially Edentulous Jaw Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dental Implants with Hyaluronic Acid

Procedure

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.

Dental Implants with Hyaluronic Acid and Particulate Bone Graft

Procedure

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.

Standard Dental Implants Placement only

Procedure

Standard surgical placement of dental implants following conventional clinical protocols without the application of any adjunctive materials.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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).

  2. Plaque Index (PI)

    Time frame: Baseline (preoperative), 8 weeks, and 16 weeks

    O'Leary plaque index

  3. Gingival Index (GI)

    Time frame: Baseline (preoperative), 8 weeks, and 16 weeks

    Gingival Bleeding Index

Sponsors and collaborators

Lead sponsor

Al-Mustansiriyah University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.