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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Dental Implants + Hyaluronic Acid | Experimental | Patients receive dental implants combined with hyaluronic acid gel applied at the implant site. |
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| 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. |
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| Group 3: Control Group: Dental Implants Alone | Active Comparator | Patients receive standard dental implants placement alone without any adjunctive materials. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Scores | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Dentistry, University of Babylon | Hillah | Babylon | Iraq | |||
| Private specialized dental center |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| D007576 | Jaw, Edentulous, Partially |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| D015921 | Dental Implants |
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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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).
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The outcomes assessor was blinded to the group allocation to prevent bias during the evaluation of soft tissue width and crestal bone measurements.
| 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. |
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| Standard Dental Implants Placement only | Procedure | Standard surgical placement of dental implants following conventional clinical protocols without the application of any adjunctive materials. |
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| Three times daily (morning, afternoon, and evening) for the first 7 days postoperatively |
| Plaque Index (PI) | O'Leary plaque index | Baseline (preoperative), 8 weeks, and 16 weeks |
| Gingival Index (GI) | Gingival Bleeding Index | Baseline (preoperative), 8 weeks, and 16 weeks |
| Hillah |
| Babylon |
| Iraq |
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009066 | Mouth, Edentulous |
| D014076 | Tooth Diseases |
| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |