The Effects of Disconnection and Reconnection of Definitive Abutments on Peri-Implant Bone Levels: A 1-year Split-Mouth Randomized Controlled Clinical Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Loma Linda University
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Changes in Peri-implant Marginal Bone Level Between Baseline (Implant Placement) and 1 Year Follow up
Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Changes in Keratinized Mucosa Width(At baseline (implant placement) and 1 year follow up)
- Changes in Lingual Mucosa Thickness(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)(12 months after surgical implantation)
Investigators
Joseph Kan, DDS
Professor
Loma Linda University