Alveolar Bone Loss, Dental Implant, Partially Edentulous Jaw
Conditions
Keywords
dental implant, Hyaluronic acid, gingiva, bone graft, Keratinized Mucosa
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.
Interventions
PROCEDUREDental 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.
PROCEDUREDental 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.
PROCEDUREStandard Dental Implants Placement only
Standard surgical placement of dental implants following conventional clinical protocols without the application of any adjunctive materials.
Sponsors
Al-Mustansiriyah University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor was blinded to the group allocation to prevent bias during the evaluation of soft tissue width and crestal bone measurements.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Iraq
Outcome results
None listed