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

April 3, 2024 updated by: Loma Linda University

The Effects of Disconnection and Reconnection of Implant Abutments on Peri-implant Bone Levels: a 1-year Prospective Study

The aim of this prospective study is to assess the effects of definitive abutment connection at the time of implant placement on bone level changes in the areas of the posterior maxilla and mandible.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 38 implants will be placed in 19 patients with at least 2 missing posterior teeth in the maxilla and the mandible for this study. Definitive prefabricated abutments will be connected at implant placement. The abutment (control group) on one of the two implants will be randomly selected to go through one complete cycle of complete disconnection and reconnection by hand at 16- (DR1), 19- (DR2), 22- (DR3), and 24- (DR4) weeks after implant surgery. The abutment (test group) on the other implant will be left undisturbed throughout the duration of the study. All implants will remain unrestored within the study period (12 months). Peri-implant bone level changes will be assessed using standardized periapical radiographs immediately after implant placement (T0), at 3-(T3), 6-(T6) and 12-(T12) month follow-up examinations and during each disconnection of the abutments.

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 Contact

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University

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
Healing abutments are connected on the implants on the day of surgery, which will be subjected to multiple disconnection and reconnection during the prosthetic phase
Experimental: Test group
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
Change in bone level between baseline surgery and 12 months
Time Frame: At baseline (prior to surgical implantation), and 12 months after surgical implantation
Bone level will be measured by periapical radiograph to assess for bone loss after dental implant
At baseline (prior to surgical implantation), and 12 months after surgical implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of radiolucency after implant
Time Frame: At baseline (prior to surgical implantation), and 12 months after surgical implantation
A successful implant will be determined by the degree of radiolucency around the implant 12 months after surgery. Radiolucency will be measured by periapical radiograph at baseline prior to surgery and at 12 months after dental implant surgery. Normal degrees of radiolucency are within 2mm at the crestal region and no radiolucency around the body of the implant
At baseline (prior to surgical implantation), and 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 16, 2023

Study Completion (Actual)

September 16, 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)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 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.

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