Overview

This trial is active, not recruiting.

Condition immediate dental implant loading
Treatments immediate loading, delayed loading
Sponsor Fölktandvården Skåne AB
Start date April 2011
End date December 2015
Trial size 50 participants
Trial identifier NCT02770846, Dnr 2011/125, RCT01BG

Summary

The purpose of this prospective randomized clinical study was to compare implant survival, patient satisfaction, and radiographic, clinical, and aesthetic outcomes following immediate loading (IL) and delayed loading (DL) of single dental implants after 1,3 and 5 years of follow-up.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Immediate loading of single dental implant in the anterior maxilla with temporary crown in central occlusion
immediate loading
(Active Comparator)
Delayed loading. 2-stage procedure with a 4 months healing period before fabrication of temporary crown.
delayed loading

Primary Outcomes

Measure
Change in level of marginal bone
time frame: Baseline (surgery), 3, 6, 12, 36, 60 months
Change in Pink esthetic score
time frame: Baseline (surgery), 3, 6, 12, 36, 60 months
Change in Oral Health Impact Profile 14 (OHIP-14)
time frame: Pre-surgery, baseline (surgery), 6, 12, 36, 60 months
Change in White esthetic score
time frame: Baseline (surgery), 3, 6, 12, 36, 60 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients of at least 18 years of age. - In need of one or more single-tooth replacements. - The single-tooth replacement needs to be in the anterior maxilla - Minimum of mesial-distal width of interdental space of 6 mm Exclusion Criteria: - General contraindications for oral surgery - Inadequate oral hygiene - Insufficient bone volume at the recipient site

Additional Information

Official title Evaluation of Immediate Loading Versus Delayed Loading in Single-implant Restorations
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Fölktandvården Skåne AB.