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

NCT07665281 — Not applicable, Completed, 36 participants, Al-Mustansiriyah University

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

RegistryNCT07665281
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment36 (Actual)
SponsorAl-Mustansiriyah University (Other)
ConditionsAlveolar Bone Loss, Partially Edentulous Jaw, Dental Implant
InterventionsDental Implants with Hyaluronic Acid, Dental Implants with Hyaluronic Acid and Particulate Bone Graft, Standard Dental Implants Placement only (Procedure)
Datesstart 2025-12-05, primary completion 2026-07-02, completion 2026-07-02, first posted 2026-06-24, last updated 2026-07-07
Locations2 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

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Group 1: Dental Implants + Hyaluronic AcidExperimentalProcedure: Dental Implants with Hyaluronic AcidPatients receive dental implants combined with hyaluronic acid gel applied at the implant site.
Group 2: Dental Implants + Hyaluronic Acid + Bone GraftExperimentalProcedure: Dental Implants with Hyaluronic Acid and Particulate Bone GraftPatients receive dental implants combined with hyaluronic acid gel and particulate bone graft applied at the implant site.
Group 3: Control Group: Dental Implants AloneActive comparatorProcedure: Standard Dental Implants Placement onlyPatients receive standard dental implants placement alone without any adjunctive materials.
  • 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.

+Outcome measures

Primary outcomes

  • Ridge Width Changes (RW) [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.
  • Bone Width (BW) [Baseline (preoperative), and 16 weeks postoperatively]: Measured in millimeters by subtracting the buccal and lingual mucosal thickness from the ridge width.
  • Change in width of keratinized tissue (KTW) [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.
  • Keratinized Tissue Thickness (KTT) [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.
  • Radiographic Mucosal Thickness (RT) [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.
  • Crestal Bone Height (BH) [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

  • Postoperative Pain Scores [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).
  • Plaque Index (PI) [Baseline (preoperative), 8 weeks, and 16 weeks]: O'Leary plaque index
  • Gingival Index (GI) [Baseline (preoperative), 8 weeks, and 16 weeks]: Gingival Bleeding Index

+Eligibility

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.

+Locations (2)

FacilityCityCountryStatus
College of Dentistry, University of BabylonHillah, BabylonIraq
Private specialized dental centerHillah, BabylonIraq