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

Primary Purpose

Bone Loss, Gum Recession

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Definitive abutment
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss focused on measuring One abutment one time, Disconnection reconnection, Definitive abutment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Loma Linda UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Test group

Arm Description

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

Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase

Outcomes

Primary Outcome Measures

Change in bone level between baseline surgery and 12 months
Bone level will be measured by periapical radiograph to assess for bone loss after dental implant

Secondary Outcome Measures

Level of radiolucency after implant
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

Full Information

First Posted
July 31, 2019
Last Updated
April 20, 2023
Sponsor
Loma Linda University
Collaborators
Nobel Biocare
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1. Study Identification

Unique Protocol Identification Number
NCT04043286
Brief Title
The Effects of Dis/Reconnection of Implant Abutments on Peri-implant Bone Levels
Official Title
The Effects of Disconnection and Reconnection of Implant Abutments on Peri-implant Bone Levels: a 1-year Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
Collaborators
Nobel Biocare

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Gum Recession
Keywords
One abutment one time, Disconnection reconnection, Definitive abutment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single center, prospective, randomized modified split mouth clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Arm Title
Test group
Arm Type
Experimental
Arm Description
Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase
Intervention Type
Device
Intervention Name(s)
Definitive abutment
Other Intervention Name(s)
On1 Base, On1 Concept
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in bone level between baseline surgery and 12 months
Description
Bone level will be measured by periapical radiograph to assess for bone loss after dental implant
Time Frame
At baseline (prior to surgical implantation), and 12 months after surgical implantation
Secondary Outcome Measure Information:
Title
Level of radiolucency after implant
Description
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
Time Frame
At baseline (prior to surgical implantation), and 12 months after surgical implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sasiya Bhumpattarachai, DDS
Phone
909-328-9742
Email
sbhumpattarachai@llu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Kan, DDS, MS
Organizational Affiliation
Loma Linda University School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuen Lok Loretta Ching, BDS
Phone
909-328-9742
Email
yching@llu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effects of Dis/Reconnection of Implant Abutments on Peri-implant Bone Levels

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