The Effects of Dis/Reconnection of Implant Abutments on Peri-implant Bone Levels

November 12, 2024 updated by: Joseph Kan, DDS, Loma Linda University

The Effects of Disconnection and Reconnection of Definitive Abutments on Peri-Implant Bone Levels: A 1-year Split-Mouth Randomized Controlled Clinical Study

The aim of this study was to evaluate the effects of definitive abutment connection at the time of implant placement on peri-implant bone levels and soft tissue changes in posterior maxilla and mandible regions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 38 implants were placed in 17 patients with at least 2 missing posterior teeth in the maxilla or the mandible for this study. Each patient received 2 or 4 implants. A definitive prefabricated abutment (test group) was randomly connected to one implant at implant placement (T0) and left undisturbed throughout the duration of the study. On the other implant, a healing abutment (control group) was connected and subjected to go through three disconnections and reconnections at 3 months (T3), 6 months (T6), and 12 months (T12) after the implant placement. Throughout the study period (1 year), all implants remained unrestored. Marginal bone level changes (MBLC) were assessed using standardized periapical radiographs taken at T0 and T12. Peri-implant soft tissue parameters including the keratinized mucosa width and lingual mucosa thickness were also recorded and evaluated.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92350
        • LOMA LINDA UNIVERSITY, School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Minimum age 18
  • Good oral hygiene
  • Healed site that possess two or more missing teeth in the maxillary or mandibular posterior region (excluding third molars)
  • Adequate bone to accommodate at least a 4.3 mm diameter and 8mm length implant at each site
  • Have at least 8mm interocclusal restorative space
  • Willing to participate and attend the planned follow-up visits.

Exclusion Criteria:

  • History of alcohol/drug dependency, or any medical, physical, or psychological factor that might affect the surgical or prosthodontic procedures and follow-up examinations
  • History of radiation therapy to the head and neck region
  • History or current habit of smoking
  • History or current habit of bruxism
  • No opposing occluding dentition or prostheses
  • Need for bone augmentation during implant placement
  • Implant insertion torque value <35 Ncm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Split mouth: Healing abutments are connected on the implants on the day of surgery, which will be subjected to multiple disconnection and reconnection during the study
Experimental: Test group
Split mouth: Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase
Device: Definitive abutment
With two height options available, On1 Base are selected depending on the thickness of the soft tissue. It remains in position from implant placement to finalization, which leaves the soft tissue undisturbed for optimized healing, moved the restorative platform of Nobel Biocare conical connection implants from bone level to tissue level, thereby simplifying the restorative procedures
Other Names:
  • On1 Base
  • On1 Concept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Peri-implant Marginal Bone Level Between Baseline (Implant Placement) and 1 Year Follow up
Time Frame: At baseline (implant placement) and 1 year follow up
Standardized digital periapical radiographs were taken at baseline (implant placement) and at the 1-year follow-up using the long-cone paralleling technique with a custom jig. Peri-implant marginal bone levels were measured on both the mesial and distal aspects to assess bone loss. Changes in peri-implant marginal bone levels were calculated by comparing the measurements at the 1-year follow-up to the baseline values.
At baseline (implant placement) and 1 year follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Keratinized Mucosa Width
Time Frame: At baseline (implant placement) and 1 year follow up
The width of the keratinized mucosa was measured at the mid-buccal aspect of the abutments using a periodontal probe with 1.0 mm markings. Measurements were repeated at the 1-year follow-up at the same location and compared to the baseline values.
At baseline (implant placement) and 1 year follow up
Changes in Lingual Mucosa Thickness
Time Frame: At baseline (implant placement) and 1 year follow up
The thickness of the lingual mucosa at each implant site was measured at the center of the implant site from the bone crest using a periodontal probe with 1.0 mm markings. Measurements were repeated at the 1-year follow-up at the same location and compared to the baseline values taken on the day of implant surgery.
At baseline (implant placement) and 1 year follow up
Implant Success Rate According to the 2017 Classification Criteria Set by the American Academy of Periodontology (AAP)
Time Frame: 12 months after surgical implantation
Success was determined by the implant's ability to meet these clinical factors, such as the absence of pain, infection, mobility, and radiographic bone loss beyond the acceptable threshold of the follow-up period, as assessed at 12 months post-surgical implantation.
12 months after surgical implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Collaborators

Nobel Biocare

Investigators

  • Principal Investigator: Joseph Kan, DDS, MS, Loma Linda University School of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Actual)

September 18, 2023

Study Completion (Actual)

September 18, 2023

Study Registration Dates

First Submitted

July 31, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 2, 2019

Study Record Updates

Last Update Posted (Actual)

December 4, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5190024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gingival Recession

Clinical Trials on Definitive abutment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe