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

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: Trial of Labor; Failure
• Intervention / Treatment: Other: Direct composite build-ups

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	5 years

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

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