Clinical Trial: Implant Abutment Dis-/Reconnection and Peri-Implant Marginal Bone Loss.
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Impact of Implant Abutment Dis-/Reconnection on Peri-Implant Marginal Bone Loss - Randomized Clinical Trial.
Brief Summary: The purpose of this study is to investigate whether the immediate definitive abutment connection to dental implant is effective in preventing marginal bone loss when compared to the conventional treatment with late abutment/implant connection, which include three disconnections and reconnections.
Detailed Summary:
The proposed study is a randomized clinical trial in which the participants will be allocated into one of the two arms according to the proposed intervention: experimental group, in which the abutments will be permanently connected immediately at the implant placement procedure; and control group (active comparator) with conventional treatment, where the abutments will be disconnected and reconnected three times.
Considering the inclusion and exclusion criteria related to oral and systemic health, a sample of participants will be selected among those partially edentulous patients who seek for dental implants treatment at the Fortaleza University School of Dentistry.
The sample size has been calculated based on the standard deviation of 0.17 mm, significance level of 5% and 80% statistical test power. To detect a clinically significant difference of 0.2 mm, each group should be composed of 11 participants. Therefore, considering a 10% margin for possible dropouts or missing data, the study will include 24 participants divided into two groups. Each participant will receive one or two implants according to his/her needs, so the study may include more than 24 implants.
A single surgeon will perform the implant surgical procedure in order to reduce variations inherent to clinical experience. After local anesthesia and incision on the top of the alveolar ridge, the bone will be exposed by the mucoperiosteal flap elevation. The mucosal thickness will be measured at implant sites, before the lingual/palatal flap elevation, with a periodontal probe.
The drilling sequence will be done according to manufacturer's recommendations, under saline solution irrigation, intermittent movements and speed up to 1200rpm.
To estimate the gingival margin stability and the long-term success of implant-supported restorations, the peri-implant marginal bone level will be assessed as primary outcome through intraoral radiographs, in a perspective of bone maintenance, bone loss or bone gain.
Original Primary Outcome: Peri-implant marginal bone level change. [ Time Frame: 3, 6, 12 and 24 months after implant surgery. ]
Current Secondary Outcome:
- Implant stability change. [ Time Frame: 3 and 6 months after implant surgery. ]The implant stability will be measured using a resonance frequency analysis equipment to confirm the implant osseointegration.
- Gingival level change. [ Time Frame: 6, 12 and 24 months after implant surgery. ]The gingival level will be measured using a periodontal probe and an acrylic stent as a reference.
- Peri-implant probing depth change. [ Time Frame: 12 and 24 months after implant surgery. ]To evaluate the peri-implant health, the probing depth will be assessed in 6 areas around the implant using the prosthetic abutment as a reference.
- Bleeding on probing change. [ Time Frame: 12 and 24 months after implant surgery. ]To evaluate the peri-implant health, the bleeding on probing will be observer or not at until 10 seconds after peri-implant probing.
Original Secondary Outcome: Same as current
Information By: Fortaleza University
Dates:
Date Received: November 19, 2015
Date Started: November 2015
Date Completion: July 2018
Last Updated: January 15, 2017
Last Verified: January 2017
