Impact of Hyaluronic Acid and Bone Graft on PeriImplant Tissue Phenotype."A Randomized Controlled Trial"
| Registry | NCT07665281 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 36 (Actual) |
| Sponsor | Al-Mustansiriyah University (Other) |
| Conditions | Alveolar Bone Loss, Partially Edentulous Jaw, Dental Implant |
| Interventions | Dental Implants with Hyaluronic Acid, Dental Implants with Hyaluronic Acid and Particulate Bone Graft, Standard Dental Implants Placement only (Procedure) |
| Dates | start 2025-12-05, primary completion 2026-07-02, completion 2026-07-02, first posted 2026-06-24, last updated 2026-07-07 |
| Locations | 2 sites in Iraq |
Related Papers Related Patents Related Grants Related Experts
All trials for Alveolar Bone Loss All trials for Partially Edentulous Jaw All trials of Dental Implants with Hyaluronic Acid All trials of Dental Implants with Hyaluronic Acid and Particulate Bone Graft
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group 1: Dental Implants + Hyaluronic Acid | Experimental | Procedure: Dental Implants with Hyaluronic Acid | Patients receive dental implants combined with hyaluronic acid gel applied at the implant site. |
| Group 2: Dental Implants + Hyaluronic Acid + Bone Graft | Experimental | Procedure: Dental Implants with Hyaluronic Acid and Particulate Bone Graft | Patients receive dental implants combined with hyaluronic acid gel and particulate bone graft applied at the implant site. |
| Group 3: Control Group: Dental Implants Alone | Active comparator | Procedure: Standard Dental Implants Placement only | Patients receive standard dental implants placement alone without any adjunctive materials. |
Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| College of Dentistry, University of Babylon | Hillah, Babylon | Iraq | |
| Private specialized dental center | Hillah, Babylon | Iraq |