Response of Hard and Soft Tissue Around the Dental Implant to 2-Piece Abutment Vs Conventional Restorative Protocols

Summary

The goal of the study is to determine whether using a two-piece definitive abutment, as opposed to a traditional two-stage healing abutment connection, will reduce the loss of crestal bone surrounding the implant and improve soft tissue adaption. With the use of a manual periodontal probe, it will be recorded at four locations per implant. In order to prevent its removal during healing, an abutment base of the definitive restorative abutment will be positioned during implant surgery. Therefore, there is no departure from the standard course of treatment. An implant and crown will be used to replace a lost tooth, which will benefit the patients.

Benefit to society: more predictable and enhanced functional and aesthetic treatment outcomes.

Benefit to Scientific Advancement: This concept will be beneficial in maintaining the peri-implant soft tissue and bone levels.

Changes in interproximal bone levels will be measured in standardized periapical digital radiographs (x-rays) once a month, which is usually not associated with any complications.

The number of visits to the hospital: On the day of implant placement, 12th-week Impression Visit, 16th-week Prosthesis Placement, 20th-week 1st Month post prosthesis, follow up, 28th-week 3rd-month post prosthesis follow-up, 40th-week 6th-month post prosthesis follow-up, 64th-week 1-year follow-up after placing the definitive restoration. On every visit, radiographs will be taken. Patients should maintain regular oral hygiene to prevent future bone loss.

No one else shall be privy to participants' details. Implant treatment for the participant is free. The participant will give consent for any advisable and necessary dental procedures, medications, or anaesthetics to be administered by the attending dentist or his supervised staff for diagnostic purposes or for implant placement. Also give consent to make radiographic and photographic records; these records may also include study models, x-rays, and blood studies. If implants fail, then they will be retreated free of charge. Participants understood and acknowledged that they agreed to be part of this clinical study, will keep up with the follow-up appointments, and if they want, they can choose to drop out of the study anytime on the course of study. That there is no force or influence to participate, that he/she can take enough time to decide whether to participate, and that he/she can ask any doubts to the PI at any point in time.

Conditions

• Partially Edentulous Mandible
• Dental Implant
• Soft Tissue Healing

Interventions

DEVICE

Definitive abutment base

Definite abutment base, this is a two-piece definitive abutment where the base is connected to the implant as soon as it is placed.This abutment will allow the tissues around the implant to heal undisturbed, thus, establishing a good and healthy periimplant soft and hard tissue with long-term stability.

DEVICE

Conventional Healing Abutment

A healing abutment of different diameters (4.3, 5, 6 mm) and heights (1.5, 3 mm) is placed on the day of the surgery, and the flaps are sutured around them to allow for tissue healing around the abutment to create an optimum emergence profile and tissue cuff around the implant and definitive abutment.

Sponsors & Collaborators

• Yenepoya Dental College

  collaborator OTHER

• Hasan Sarfaraz

  lead OTHER

Principal Investigators

• Hasan Sarfaraz, MDS · Yenepoya Dental College

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-13

Primary Completion

2020-12-12

Completion

2022-04-14

Countries

• India

Study Locations