N/A N=38 Randomized Treatment

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

Bone Loss · Implant Complication · Gingival Recession

Bottom Line

View on ClinicalTrials.gov: NCT04043286 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Changes in Peri-implant Marginal Bone Level Between Baseline (Implant Placement) and 1 Year Follow up — 0.80; 0.32 millimeters — p=0.009

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Definitive abutment (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Loma Linda University
Primary completion: Sep 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Peri-implant Marginal Bone Level Between Baseline (Implant Placement) and 1 Year Follow up	0.80; 0.32	0.009 sig
SECONDARY Changes in Keratinized Mucosa Width	0.90; 0.42	0.049 sig
SECONDARY Changes in Lingual Mucosa Thickness	0.71; 0.38	0.053
SECONDARY Implant Success Rate According to the 2017 Classification Criteria Set by the American Academy of Periodontology (AAP)	0; 0	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04043286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.