Influence of the Primary Stability and Temporary Prosthetics

Overview

The goal of this clinical trial is to to determine how different primary implant stability and loading management affect implant osseointegration and further function after one year. The main questions it aims to answer are: is primary stability of inserted implant needed for implant integration? Does primary stability and restoration mode of the implant influence marginal bone stability of that implant? Researchers will compare crestal bone levels and primary stability of the implant after insertion in 3 groups. Subjects will be assigned to groups, acoording to primary stability developed during insertion of the implant. Study groups - (1) If stability is low (5-10 N/cm), Megagen BlueDiamond implants will be inserted, and a temporary prosthesis will not be placed; the implant will be sutured; (2) If stability is moderate (15-35 N/cm), Megagen BlueDiamond implants will be inserted, and a custom plastic gingiva-forming healing abutment will be placed; (3) If stability is high (40 N/cm and higher), Megagen BlueDiamond implants will be inserted, and a temporary plastic crown will be placed. Primary outcome of the study will be implant integration, secondary ourtcomes - implant insertion depth during insertion and after osseointegration, marginal bone stability after prosthesis delivery and after one year, determination of the PES (pink esthetic score) index after prosthesis delivery and after 1 year, determination of the ISQ value after implant insertion and after osseointegration, changes in gingival volume around the implants after 1 year, determination of the Plaque Index (PI) after prosthesis delivery and after 1 year, determination of the Probing Pocket Depth (PPD) after prosthesis delivery and after 1 year, determination of the Bleeding on Probing (BOP) index after prosthesis delivery and after 1 year.

In Group 1 and Group 2 participants in this study were scheduled for tooth extraction followed by immediate implant placement. One hour prior to the procedure, patients were administered 1 g of amoxicillin orally, which was continued at a dosage of twice daily for one week after the procedure. Teeth were extracted under local anesthesia using 4% articain with epi-nephrine 1:100000 (Ubistesin forte, 3M ESPE, USA), with an emphasis on minimizing trauma and avoiding flap elevation, employing root sectioning if necessary. Care was taken to preserve the marginal gingiva and papillae. Following extraction, the socket was cleaned and assessed. Osteotomies were created using the original drills in a sequence specified by the implant manufacturer. The implant was placed centrally in the me-sio-distal aspect and more towards the lingual/palatal side of the socket. The insertion torque was recorded with manual torque wrench. Anatomical or individual healing abutments were used after implant placement. Individual healing abutments were crafted chairside using original titanium temporary abutments and flowable composite (3M Supreme Filtek Flow, 3M ESPE, USA), creating critical and subcritical contours. The composite was polished meticulously. All immediate implant sites were grafted with allogenic cortical/cancellous particulate (1000-1700 micron) bone and healing abutments were secured on the implants with 15 Ncm torque. Postoperative instructions were provided both verbally and, in a booklet, advising patients to rinse their mouths twice daily for 2 weeks with a commercially available mouth rinse containing 0.12% chlorhexidine di-gluconate. After 4 months, the osseointegration of implants was evaluated for presence or ab-sence of following symptoms: pain, recurrent peri-implant infections, mobility on manual palpation and continuous peri-implant radiolucency. If those symptoms were absent, implant was deemed successfully integrated and silicone impressions for final restorations were taken. Screw-retained full-contour zirconia crowns with ultra-polished subgingival areas, using the protocol described by Linkevicius et al. 2017 were delivered. The access holes were filled with Teflon tape, and while the top 1 mm was sealed with flowable composite (Figure 3D). Individual oral hygiene instructions were provided both verbally and in booklet form. Scheduling of follow-up visits were carried out after 1 year of last dental visit. In Group 3 Following the extraction of molars under local anaesthesia, socket was debrided using surgical curette until hard bone surface was felt. Following copious irrigation with saline, an ultrawide diameter implant(8.0mm X8.0mm; Megagen Anyridge) was placed in the depth of the socket with zero insertion torque (T1). Socket was then allowed to fill with fresh blood. The remaining part of the socket present coronal to implant platform (measuring 6mm approx.) was then sealed with xenograft particles in a similar manner to alveolar ridge preservation. This was carried out in order to prevent the resorption of buccolingual width while simultaneously utilizing the benefits of immediate implant placement. In order to separate the xenograft particles from the oral microenvironment, a non-resorbable d-PTFE membrane was placed with its edges inserted into buccal and lingual flaps. This was further secured using criss cross sutures(5-0 Polyglycolic acid) along the occlusal surface. Suture removal was done 10 days post operatively and the site was allowed to heal for 04 months. d-PTFE membrane was then removed which revealed completely epithelialized with xenograft particles integrated over the implant platform which was confirmed on the radiograph. Stage II implant exposure surgery was performed after 04 months of implant placement. Implant was deemed successful if there was no implant mobility and apparently healthy mucosa around implant.