Immediate Loading Versus Delayed Loading in Single-implant

NCT ID: NCT02770846

Last Updated: 2020-03-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Purpose: The objective of the present prospective randomized clinical study was to compare the overall treatment outcome following immediate loading (IL) and delayed loading (DL) of single implants after 5 year of follow-up.

Patients with a missing maxillary tooth (15-25) were randomly assigned to IL or DL. The protocol included implant installation in healed sites, immediate loading, delayed loading, temporary screw-retained restoration, and replacement with a permanent single implant crown. Outcome measures were implant survival, marginal bone level, soft tissue changes, papillae index, pink, and white esthetic score (PES and WES), patient judged aesthetics, and oral health impact profile (OHiP-14).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immediate Dental Implant Loading

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Immediate loading

Immediate loading of single dental implant in the anterior maxilla with temporary crown in central occlusion

Group Type EXPERIMENTAL

Immediate loading

Intervention Type PROCEDURE

Delayed loading

Delayed loading. 2-stage procedure with a 4 months healing period before fabrication of temporary crown.

Group Type ACTIVE_COMPARATOR

Delayed loading

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Immediate loading

Intervention Type PROCEDURE

Delayed loading

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Folktandvården Skåne AB

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ann Wennerberg, DDS, Phd

Role: STUDY_DIRECTOR

Malmö University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre of Dental Specialist Care

Malmo, Skåne County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Dnr 2011/125

Identifier Type: OTHER

Identifier Source: secondary_id

RCT01BG

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Immediate Implant Placement in the Molar Regions
NCT00226148 COMPLETED EARLY_PHASE1