The Effect of Ground and Unground Enamel on the Clinical Performance of Direct Composite Build-ups

September 27, 2023 updated by: Mustafa Demirci, Istanbul University

The Effect of Ground and Unground Enamel on the Clinical Performance of Direct Composite Build-ups After Orthodontic Treatment: Five Years of Follow-up

Twenty-four patients participated in the study. Patients received direct composite build-ups for diastema closure.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The restorations were performed separately by grounding and ungrounding the enamel on the proximal surfaces in symmetrical teeth.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • good oral hygiene, no periodontal or pulpal disease, interarch tooth size discrepancies (Bolton discrepancy) after orthodontic treatment

Exclusion Criteria:

  • uncontrollable parafunctions, insufficient or poor oral hygiene, periodontal or gingival disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Restoration
Other: Direct composite build-ups
Direct composite build-ups application
Experimental: Arm 2
Evaluate
Other: Direct composite build-ups
Direct composite build-ups application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success rate
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2011

Primary Completion (Actual)

October 30, 2015

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

October 19, 2022

First Submitted That Met QC Criteria

October 20, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2011-97

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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