Evaluation of Patient Satisfaction Following Anterior Composite Restorations: Immediate and One-Week Comparisons

NCT07174271 | Completed

• 1 other identifier: 09.2023.816
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary The goal of this observational study is to learn about patient-centered evaluations of anterior composite restorations performed under rubber dam isolation in adults treated at a university dental clinic. The main questions it aims to answer are: How do patients rate their restorations immediately after treatment? Do patient evaluations change one week after treatment compared to immediate assessment? The study group consisted of vital maxillary central and lateral incisors and canines. Individuals requiring partial diastema or full-coverage restorations in one to six anterior teeth were included in the study. All restorative procedures were performed under rubber dam isolation in accordance with standard protocols. Restorations were immediately evaluated by patients after treatment and reassessed during a one-week follow-up session. Evaluations were conducted using questions based on Fédération Dentaire Internationale (FDI) criteria. However, since the FDI criteria were primarily designed for dentists, it was not possible for patients to score the restorations according to the classic model. Instead, patient assessment was achieved by asking them to give a score between 0 and 10 for each category. A total of 50 patients were included in the study, and the number of teeth evaluated varied depending on the number of anterior restorations performed on each patient. In the questionnaire, patients were asked a total of five questions regarding the esthetic anatomical form , color harmony and translucency , surface smoothness, adjacent mucosal conditions , and post-operative sensitivity.

Conditions

Composite Restorations

Keywords

composite restorations; Patient satisfaction; control sessions

Outcome Measures

Primary Outcomes (1)

• Change in Patient Satisfaction Scores for Anterior Composite Restorations from Post-Treatment to 1-Week Follow-up

  Patient satisfaction with anterior composite restorations was assessed immediately after treatment and at a 1-week follow-up visit. Evaluations were performed using a patient-adapted questionnaire based on the Fédération Dentaire Internationale (FDI) criteria. Because FDI criteria were originally designed for dentist-based assessment, the questions were simplified into a 0-10 numeric rating scale for patients. The questionnaire included five domains: Esthetic Anatomical Form Scale: 0-10(0 = very poor anatomical form, 10 = excellent anatomical form) Color Harmony and Translucency Scale: 0-10(0 = severe mismatch in color/translucency, 10 = perfect match with natural tooth) Surface Smoothnes Scale: 0-10(0 = very rough surface, 10 = perfectly smooth surface) Adjacent mucosal condition, Scale: 0-10(0 = severe inflammation, bleeding or pathology, 10 = healthy adjacent mucosa with no sign) Post-operative Sensitivity and Tooth Vitality Scale: 0-10 (0 = no sensitivity with preserved vitality)

  Immediately after treatment and at 1-week follow-up

Study Arms (1)

Anterior Composite Restoration Group

Anterior Composite Restoration Group - Single cohort of healthy participants receiving direct anterior composite restorations on maxillary central/lateral incisors or canines. Eligibility included vital anterior teeth with healthy periodontium and an esthetic need (e.g., partial diastema closure or full-coverage/esthetic restoration) in 1-6 teeth. Procedures were performed under rubber-dam isolation with a standardized protocol in the same clinic. Patient-reported outcomes were collected immediately post-treatment and at 1-week using a patient-adapted, FDI-based questionnaire (A4, A3, A1, C15, C11; 0-10 scale).

Other: Patient satisfaction survey upon completion of anterior composite restorations and during follow-up sessions

Interventions

Patient satisfaction survey upon completion of anterior composite restorations and during follow-up sessions OTHER

This study focuses on evaluating patient satisfaction with anterior composite restorations immediately after treatment and during subsequent follow-up visits. A structured questionnaire, based on modifications of the Fédération Dentaire Internationale (FDI) criteria, was administered to patients. Since the original FDI criteria were primarily designed for dentist-based evaluation, the questions were adapted into a patient-friendly format. Participants were asked to rate restorations across multiple domains, including esthetic anatomical form, color harmony and translucency, surface smoothness, the condition of the adjacent mucosa, and post-operative sensitivity and tooth vitality. Each parameter was scored on a numerical scale ranging from 0 to 10, allowing patients to express their subjective perception of treatment outcomes. By collecting these patient-reported outcomes both immediately after the procedure and during follow-up sessions, the study aims to provide a comprehensive under

Anterior Composite Restoration Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of systemically healthy individuals aged 18 to 35 years who are capable of understanding and providing informed consent. Eligible participants must present with clinically healthy gingiva and periodontium, no bleeding or plaque accumulation, and vital maxillary incisors and canines (teeth 11, 12, 13, 21, 22, 23) without signs of irreversible pulpitis. Individuals with systemic diseases, disabilities, poor oral hygiene compliance, contraindications to rubber dam placement (e.g., asthma, mouth breathing, partially erupted or malposed teeth, latex allergy), or with signs of periapical or pulpal pathology will be excluded.

You may qualify if:

• years old
• Sufficient cognitive ability to understand the consent process
• Clinically healthy gingiva and periodontium
• No bleeding or plaque accumulation
• Vital upper incisors and canines without signs of irreversible pulpitis (11-12-13-21-22-23)

You may not qualify if:

• Any disability (mental health conditions, mental disabilities and physical disabilities)
• Systemic diseases or serious medical risks (cardiovascular disorders, diabetes, hypertension, epilepsy)
• Compliance problems, inability to maintain hygiene after treatment
• Patients contraindicated for rubber dam placement (patient with asthma diagnosis, mouth breathing, partially erupted teeth, excessively malposed teeth and latex allergy)
• Signs of periapical pathology or pulpal posterior or anterior pathology

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Dentistry

Istanbul, Istanbul Asya Kitasi, 34846, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: June 2, 2023
• Primary Completion: December 22, 2023
• Study Completion: June 21, 2024
• Last Updated: September 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)