Bruxism Awareness Prior to Dental Implant Treatment

NCT07088887 | Completed DMC

• 1 other identifier: BAHAR1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Bruxism is a parafunctional habit characterized by clenching or grinding of the teeth and/or mandibular thrusting, which may occur during sleep or wakefulness. It is associated with various dental complications, including implant failures. Despite its prevalence, awareness of bruxism among patients remains limited, and diagnostic methods vary. This study aims to evaluate the presence and type of bruxism in patients undergoing dental implant treatment and to assess their awareness levels. The findings may help prevent implant-related complications by supporting early identification and appropriate management of bruxism. Research Questions What is the prevalence of awake and sleep bruxism in patients scheduled for dental implant treatment? To what extent are patients aware of their bruxism habits prior to treatment? What are the most common signs and symptoms of bruxism observed in this patient group? Is there a correlation between patients' self-reported bruxism and clinical findings? Can increased bruxism awareness before implant procedures help reduce the risk of future implant and prosthetic complications?

Conditions

Bruxism

Keywords

bruxism; dental implant; Fonseca Anamnestic Index; Perceived Stress Scale-14; awareness.

Outcome Measures

Primary Outcomes (1)

• diagnosis of bruxism

  Bruxism assessment in this study was based on both clinical examination and self-reported measures. Clinical diagnosis followed the 2018 international consensus criteria, requiring at least two of the following signs: masseter muscle pain or hypertrophy (extraoral), dental wear, linea alba on the buccal mucosa, or recurrent restoration failures (intraoral). Self-reported bruxism was evaluated using a standardized questionnaire based on Lobbezoo et al.'s grading system, distinguishing between awake and sleep bruxism.

  Baseline (before dental implant surgery)

Secondary Outcomes (1)

• Stress Level

  Baseline (before dental implant surgery)

Study Arms (1)

Bruxism group

The study group included patients aged 18-65 who were systemically healthy and suitable for implant treatment. Collected data covered demographic variables (age, gender), systemic and periodontal health status, and detailed clinical findings. Bruxism was assessed both clinically-based on signs such as masseter hypertrophy and dental wear-and through self-reported questionnaires to determine its type (awake or sleep). Patients also completed the Fonseca Anamnestic Index (FAI) to evaluate temporomandibular disorder (TMD) severity and the Perceived Stress Scale-14 (PSS-14) to assess emotional stress levels. Additionally, a bruxism awareness questionnaire was administered. All evaluations were performed prior to implant surgery using standardized diagnostic forms and validated scales.

Other: control group

Interventions

control group OTHER

The control group included patients aged 18-65 who were systemically healthy, had no clinical or self-reported signs of bruxism, and were eligible for implant treatment. Data collected included demographic characteristics (age, gender), systemic and periodontal health status, and clinical examination findings confirming the absence of bruxism. These patients also completed the Fonseca Anamnestic Index (FAI) to assess temporomandibular disorder (TMD) symptoms and the Perceived Stress Scale-14 (PSS-14) to evaluate emotional stress levels. A bruxism awareness questionnaire was also applied to determine baseline knowledge in individuals without bruxism. All assessments were conducted before implant surgery using standardized diagnostic tools.

Bruxism group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of 150 systemically healthy adult patients aged 18 to 65 who applied to the Department of Periodontology at Gülhane Faculty of Dentistry, University of Health Sciences, Ankara, Turkey, between March and June 2025. All participants were seeking dental implant therapy. The sample represents a clinical population attending a tertiary care academic dental center, with diverse educational and socioeconomic backgrounds. Patients with intellectual disabilities, psychiatric disorders, or conditions impairing questionnaire comprehension were excluded. This observational cohort was selected to evaluate the presence of bruxism and patient awareness prior to implant placement.

You may qualify if:

• Participants included in the study were individuals aged between 18 and 65 years,
• who were systemically healthy and
• able to comprehend and respond to the questionnaire items

You may not qualify if:

• Individuals with intellectual disabilities,
• suicidal tendencies, dementia,
• or psychosis were excluded from the study.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Health Sciences University Gulhane Faculty of Dentistry,

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bruxism

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• GÜLBAHAR USTAOĞLU, Assoc Prof

  GÜLHANE DİŞ HEKİMLİĞİ FAKÜLTESİ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 28, 2025
• Study Start: March 1, 2025
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)