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

Comparison of the Stability of the Peri-implant Hard and Soft Tissues with the Use of One-time Definitive Abutment (on 1 Concept) and the Conventional 2 Stage Implant Connection

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant; Partially Edentulous Mandible; Soft Tissue Healing
• Intervention / Treatment: Device: Definitive abutment base; Device: Conventional Healing Abutment

Detailed Description

An in-vivo clinical assessment and radiologic study protocol was developed and approved by the ethics committee of the Yenepoya University in Mangalore, in accordance with the Declaration of Helsinki. All patients provided written informed consent prior to the performance of any study procedures, and only data collected after the patients had signed informed consent were considered during the study analysis. A single-center, open, randomized parallel-group trial was conducted to compare the peri-implant tissue response of the abutment base treatment (test group) to that of a conventional restorative workflow with a healing abutment (control group). Patients underwent clinical assessments for the replacement of one or more missing mandibular posterior teeth with an implant-supported crown. Pre-operative CBCT scans were taken for all the patients to assess the quality and quantity of bone at the implant recipient sites.

All the surgeries were carried out by a skilled surgeon with minimal hard and soft tissue trauma during which NobelParallel TiUnite CC Implants (Nobel Biocare AB, Göteborg, Sweden) with diameters ranging from 4.3 mm to 5 mm and lengths from 10 mm to 11.5 mm were placed in healed edentulous sites in the posterior mandible in an equicrestal position. All procedures were performed using crestal incision with a full-thickness flap raised. The implants were placed at the crest of alveolar bone; no bone mill was used during the On1 base seating. The patients received broad-spectrum antibiotics for 5 days and analgesics for 2 days. The implant placement (IP) surgery was considered the baseline and was referred to as such. The On1 base (height 1.75 mm) and the On1 healing cap (Nobel Biocare AB) were placed in the test group, while the healing abutment (Conical Connection RP ø 6 x 5 mm; Nobel Biocare AB) was placed in the control group. The soft tissue was sutured (with sutures removed after 1 week), and the site was allowed a 12-week non-submerged healing, at which point the conventional tray impression was taken. At 16 weeks, a prosthetic crown (made in the university lab) was delivered, which was designated as the definitive prosthesis delivery (DPP), The follow-up appointments took place at 1-3-6 months and 1-year post-DPP.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Mangaluru, Karnataka, India, 575018
      • Yenepoya Dental College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Definite abutment base; 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; 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.
Active Comparator: Conventional healing abutment; Universal healing abutment and the universal base abutment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-Implant Tissue Health	A clinical peri-implant soft tissue health assessment was made using four different indices or measures; a positive finding in any of the two indices or measures would indicate compromised tissue health. It was recorded at 2 buccal and 2 lingual sites per implant with the aid of a manual periodontal probe at 4 time intervals: Day of Prosthesis Placement, 1-, 3-, 6-month, and 1-year post prosthesis placement. It was done using modified plaque index (mPLI with score 0-plaque seen to 3-visibly detectable plaque), modified sulcus bleeding index (mSBI with score 0-no bleeding to 3-heavy or profuse bleeding), mean probing depth (mPD) measured in millimeters with a plastic, color-coded periodontal probe (Mombelli et al. 1987) from 4 different sides: mesiobuccal, distobuccal, mesiolingual, and distolingual, and the width of peri-implant keratinized mucosa (KM) measured in millimeters in the mid-buccal and lingual sites.	I year follow up

Collaborators and Investigators

• Sponsor: Hasan Sarfaraz
• Collaborators: Yenepoya Dental College
• Investigators: Principal Investigator: Hasan Sarfaraz, MDS, Yenepoya Dental College

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2019
• Primary Completion (Actual): December 12, 2020
• Study Completion (Actual): April 14, 2022

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: 2018/193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As a requirement for ethical clearance, we had informed the patient that their individual data will be kept confidential and will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No