NCT04043286

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

Completed NA Results posted Last updated 4 December 2024

What this trial tests

NA trial testing Definitive abutment in Bone Loss in 19 participants. Completed in 18 September 2023.

Timeline

30 September 2019

Primary endpoint
18 September 2023

18 September 2023

Quick facts

Lead sponsor	Loma Linda University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	30 September 2019
Primary completion	18 September 2023
Estimated completion	18 September 2023
Sites	1 location across United States

Drugs / interventions tested

• Definitive abutment

Conditions studied

• Bone Loss — all drugs for Bone Loss →
• Implant Complication — all drugs for Implant Complication →
• Gingival Recession — all drugs for Gingival Recession →

Sponsor

Loma Linda University

Who can join

18 and older, any sex, with Bone Loss or Implant Complication. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Changes in Peri-implant Marginal Bone Level Between Baseline (Implant Placement) and 1 Year Follow up Primary · 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.

Group	Value	95% CI
Control Group	0.80	± 0.92
Test Group	0.32	± 0.47

Changes in Keratinized Mucosa Width Secondary · 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.

Group	Value	95% CI
Control Group	0.90	± 0.77
Test Group	0.42	± 0.42

Changes in Lingual Mucosa Thickness Secondary · 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.

Group	Value	95% CI
Control Group	0.71	± 0.59
Test Group	0.38	± 0.26

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

Group	Value	95% CI
Control Group	0
Test Group	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.