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

Not Applicable
Completed
Conditions
Bone Loss
Implant Complication
Gingival Recession
Interventions
Device: Definitive abutment
Registration Number
NCT04043286
Lead Sponsor
Loma Linda University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
19
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Test groupDefinitive abutmentDefinitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase
Primary Outcome Measures
NameTimeMethod
Changes in Peri-implant Marginal Bone Level Between Baseline (Implant Placement) and 1 Year Follow upAt 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 Outcome Measures
NameTimeMethod
Changes in Keratinized Mucosa WidthAt 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.

Changes in Lingual Mucosa ThicknessAt 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.

Implant Success Rate According to the 2017 Classification Criteria Set by the American Academy of Periodontology (AAP)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.

Trial Locations

Locations (1)

Loma Linda University, School of Dentistry

🇺🇸

Loma Linda, California, United States

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