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

NCT06818890 | Completed

• 1 other identifier: 2018/193
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Crestal Bone levels

  The crestal bone level changes at the mesial and distal interproximal areas were captured at baseline (implant placement), 1-, 3-, 6 months, and 1-year post-restoration. Intra-oral periapical digital radiographs using the digital radiograph sensor (Gendex Dental Systems, Kavo, USA) and measured in millimeters using the measuring tool in the bundled software VixWin. The process was standardized by a positioning/paralleling device (Gendex, Kavo, Germany). The radiographs were verified for any distortion by measuring the distance between the head of the implant and the apex and using the known length of the implant. The mesial and distal crestal bone levels were calculated by determining the distance from the implant head to the first visible bone contact in millimeters.

  I year follow up

Secondary Outcomes (1)

• Peri-Implant Tissue Health

  I year follow up

Study Arms (2)

Definite abutment base

EXPERIMENTAL

The On1 base (height 1.75 mm) and the On1 healing cap and On1 abutment (Nobel Biocare AB). it is a two-piece abutment of which the base is connected to the implant on the day of implant placement.

Device: Definitive abutment base

Conventional healing abutment

ACTIVE COMPARATOR

Universal healing abutment and the universal base abutment

Device: Conventional Healing Abutment

Interventions

Definitive abutment base DEVICE

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.

Definite abutment base

Conventional Healing Abutment DEVICE

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.

Conventional healing abutment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adequate width and height of bone for the placement of appropriate size implant(s).
• Well-healed edentulous sites with a minimum of 2 mm of soft tissue thickness.
• Patients willing to participate by giving informed consent.
• Patients agreeing to attend the planned follow-up visits.

You may not qualify if:

• Medically compromised patients where surgery was contraindicated.
• Patients with poor oral hygiene and/or suffering from periodontal disease.
• Patients with insufficient quantity/quality of bone.
• Patient with edentulous sites with a lack of attached gingiva.
• Patients with edentulous sites with insufficient prosthetic space.
• Patients with a history of parafunctional occlusal habits.
• Tobacco or alcohol use or drug dependency.

Sponsors & Collaborators

• Hasan Sarfaraz: lead
• Yenepoya Dental College: collaborator

Study Sites (1)

Yenepoya Dental College Hospital

Mangaluru, Karnataka, 575018, India

Location

Study Officials

• Hasan Sarfaraz, MDS

  Yenepoya Dental College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 11, 2025
• Study Start: March 13, 2019
• Primary Completion: December 12, 2020
• Study Completion: April 14, 2022
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)