Comparative Study of Peri-Implant Tissue Response after Implant Placement Using Para-Crestal versus Mid-Crestal Incision: A Randomized Controlled Trial.

BACKGROUND : Incision design plays an important role in the peri-implant healing and long-term implant success. Existing literature provides limited and inconsistent evidence regarding the  superiority of para-crestal versus mid-crestal incision. Most available studies are animal based for short follow-up periods, with few well-designed randomized clinical trials in humans. Previous human  studies  observed better healing and less pain with para-crestal incisions during early follow-up. Long-term effects on crestal bone levels and peri-implant tissue health remain unclear. Hence, this trial with a follow up period of 6-months, has been designed  in an Indian population to evaluate peri-implant crestal bone level changes and the clinical health around dental implants that will be placed by either flap designed with para-crestal incision or with mid-crestal incision. Additionally, the implant fixture placement surgical wound healing will be compared over a follow-up period of 1-month and the participant’s perception of pain will be compared upto 7-days.

AIM :To evaluate and compare over a follow-up period of 6 months, peri-implant crestal bone level changes and the clinical response around dental implants that will be placed by either flap designed with a para-crestal incision or with mid-crestal incision. Additionally, to evaluate and compare the implant fixture placement surgical wound healing over a follow-up period of 1 month and the participant’s perception of pain until 7-days after surgery.

MATERIAL AND METHOD : A Randomized Controlled Trial of 20 participants who are presenting with partially edentulous and systemically healthy will be selected from out-patients visiting the department and an informed consent will be administered.The participants will be randomized into two groups, one is test group (n=10) in which we will placed implants after flap designed with para- crestal incision and other is controlled group (n=10) in which we will placed implants after flap designed with mid- crestal incision. Follow- up and data collection will be done at Baseline (1/2 hour), 4 days, 7 days, 1 month, 3 months, and 6 months to check Participant’s Perception of Pain with Universal Pain Assessment Tool, Peri-implant crestal bone level, Early Wound Healing Score, Peri-implant Radiolucencies, modified Plaque Index, modified Sulcus Bleeding Index, Peri-implant Mucosal Index, Implant Mobility Index, Peri-implant Sulcus Probing Depth, Peri-implant Clinical Attachment Level, Width of Peri-implant Keratinized Mucosa, Peri-implant Suppuration.

DATA ANALYSIS : The data will be analysed statistically with standard analysis of variance at a level of significance of p value < or = 0.05.