NCT06254885

Insertion Protocol of Convergent Transmucosal Design Implants

Clinical and Radiographic Evaluation of Equicrestal and Subcrestal Positioning of a Tissue Level Implant With Convergent Transmucosal Profile - Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Cagliari · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this randomized clinical study is the evaluation of the peri-implant mucosal tissues and the marginal bone level, after positioning the transition shoulder from the intraosseous to the transmucosal portion, with an equicrestal position (at the level of the bone crest) or subcrestal (under the bone crest level).

Detailed description

The primary outcomes will be the measurement of the marginal bone level (MBL) at various time intervals and the evaluation of the soft tissues according to a score defined as Pink Esthetic Score (PES). Secondary outcomes will be plaque index (PI); the bleeding index (BI), biological complications (peri-implant mucositis, peri-implantitis, abscesses), implant failure, prosthetic complications (chipping, fractures) and prosthetic failure. The subjects recruited for the study will be those belonging to the oral surgery department of the San Giovanni di Dio Hospital in Cagliari. Each patient will receive only one implant or, in any case, only one implant per patient will be included in the analysis. A random sequence will be generated via Randomization.com, useful for assigning patients into the equicrestal and subcrestal implant placement groups. All patients will undergo the same preoperative, intraoperative and postoperative procedures. Preoperative procedures An intraoral radiograph of the edentulous site will be performed. Upper and lower alginate impressions will be made on each patient for planning and fabrication of surgical guides, all patients will receive rigorous oral hygiene and instructions will be provided to improve and maintain home oral hygiene. Intraoperative procedures After local anesthesia of the site to be operated on, a full thickness mucoperiosteal flap will be elevated, after lifting the flap the implant site will be prepared according to the manufacturer's protocol. Before implant placement, the sealed envelope will be opened for random assignment of the patient to one of the two groups. The implant will therefore be positioned, depending on the assignment group, in an equicrestal or subcrestal position, in the latter case a further step with the last preparation drill will be performed to deepen the site. The flap will be sutured after placement of the healing screw and specific hygiene instructions for the healing site will be given to the patient. The appropriate analgesic and antibiotic therapy will be prescribed. An intraoral x-ray will be performed in a standardized and repeatable manner to assess bone levels. The patient will be followed following the following follow-up scheme, reserving the right to recall the patients involved even at longer time intervals to evaluate the aforementioned outcomes also in the medium (24 months) and long (5-10 years) term. 1. week: healing check 2. weeks: healing check and suture removal 1 month: healing check 3 months: prosthesis and intraoral x-ray, measurement of soft tissue parameters via PES after positioning of the prosthetic crown 6 months: intraoral x-ray and PES 12 months: intraoral x-ray and PES The marginal bone level will be measured using ImageJ software (NIH freeware) on the distal and mesial aspects of each implant at each time point where it is foreseen.

Conditions

• Implant Site Reaction

Interventions

Type	Name	Description
PROCEDURE	Equi-crestal Implant placement	A site will be prepared through consecutive drillings on an edentulous space of the osseous ridge after flap elevation. Then a titanium fixture will be screwed that will serve, after osseointegration, to carry a dental prosthesis. The implant will be screwed until the shoulder (upper marginal part of the implant) is exactly at the same level as the bone of the maxillary/mandibular edentulous crest.
PROCEDURE	Sub-crestal Implant placement	A site will be prepared through consecutive drillings on an edentulous space of the osseous ridge after flap elevation. Then a titanium fixture will be screwed that will serve, after osseointegration, to carry a dental prosthesis. The implant will be screwed until the shoulder (upper marginal part of the implant) is 1mm below the level of the bone crest.

Timeline

• Start date: 2024-02-14
• Primary completion: 2024-06-30
• Completion: 2025-06-30
• First posted: 2024-02-12
• Last updated: 2024-02-16

Locations

1 site across 1 country: Italy