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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
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.
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 surgical placement of dental implants following conventional clinical protocols without the application of any adjunctive materials.
College of Dentistry, University of Babylon
Hillah, Babylon, Iraq
Private specialized dental center
Hillah, Babylon, Iraq
Ridge Width Changes (RW)
The changes in Ridge Width is measured at the reference points using a digital vernier caliper.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Immediate postoperative, 8 weeks, and 16 weeks
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).
Time frame: Three times daily (morning, afternoon, and evening) for the first 7 days postoperatively
Plaque Index (PI)
O'Leary plaque index
Time frame: Baseline (preoperative), 8 weeks, and 16 weeks
Gingival Index (GI)
Gingival Bleeding Index
Time frame: Baseline (preoperative), 8 weeks, and 16 weeks
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