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

NCT07665281 | Completed

• 1 other identifier: MUOSU/POST-202615
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Alveolar Bone Loss; Partially Edentulous Jaw; Dental Implant

Keywords

dental implant; Hyaluronic acid; gingiva; bone graft; Keratinized Mucosa

Outcome Measures

Primary Outcomes (6)

• Ridge Width Changes (RW)

  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)

  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)

  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)

  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)

  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)

  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 Outcomes (3)

• Postoperative Pain Scores

  Three times daily (morning, afternoon, and evening) for the first 7 days postoperatively

• Plaque Index (PI)

  Baseline (preoperative), 8 weeks, and 16 weeks

• Gingival Index (GI)

  Baseline (preoperative), 8 weeks, and 16 weeks

Study Arms (3)

Group 1: Dental Implants + Hyaluronic Acid

EXPERIMENTAL

Patients receive dental implants combined with hyaluronic acid gel applied at the implant site.

Procedure: Dental Implants with Hyaluronic Acid

Group 2: Dental Implants + Hyaluronic Acid + Bone Graft

EXPERIMENTAL

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

Group 3: Control Group: Dental Implants Alone

ACTIVE COMPARATOR

Patients receive standard dental implants placement alone without any adjunctive materials.

Procedure: Standard Dental Implants Placement only

Interventions

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.

Group 1: Dental Implants + Hyaluronic Acid

Standard Dental Implants Placement only PROCEDURE

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

Group 3: Control Group: Dental Implants Alone

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.

Group 2: Dental Implants + Hyaluronic Acid + Bone Graft

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (2)

College of Dentistry, University of Babylon

Hillah, Babylon, Iraq

Location

Private specialized dental center

Hillah, Babylon, Iraq

Location

MeSH Terms

Conditions

Alveolar Bone Loss; Jaw, Edentulous, Partially

Interventions

Dental Implants; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Jaw, Edentulous; Jaw Diseases; Mouth, Edentulous; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor was blinded to the group allocation to prevent bias during the evaluation of soft tissue width and crestal bone measurements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized, controlled, parallel-group clinical trial with three arms: Group 1 (Dental Implants + Hyaluronic Acid), Group 2 (Dental Implants + Hyaluronic Acid + Particulate Bone Graft), and a Control Group (Dental Implants alone).

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: December 5, 2025
• Primary Completion: July 2, 2026
• Study Completion: July 2, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (2)