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Completed

NCT Number: NCT07088887

Bruxism Awareness Prior to Dental Implant Treatment

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?

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Key information

Conditions

Bruxism Behavior Habits Stomatognathic Diseases Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Sciences University Gulhane Faculty of Dentistry,

Ankara, Turkey (Türkiye)

About this study

This observational study involves systemically healthy adult patients scheduled for dental implant treatment at a university dental faculty. Clinical examinations were performed to detect characteristic signs of bruxism, and validated self-report tools-including the Bruxism Questionnaire, Fonseca Anamnestic Index, and Perceived Stress Scale-were used to assess both subjective awareness and emotional stress. Additionally, a customized awareness questionnaire was administered to evaluate patients' perceptions and knowledge of bruxism.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. diagnosis of bruxism

    Time frame: Baseline (before dental implant surgery)

    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.

Secondary outcomes

  1. Stress Level

    Time frame: Baseline (before dental implant surgery)

    The Perceived Stress Scale-14 (PSS-14), developed by Cohen et al. in 1983, was used to assess the level of emotional stress. This self-reported questionnaire comprises 14 items that evaluate the frequency of stress-related thoughts and feelings experienced by the respondent over the past month. Participants rate each item on a four-point Likert scale ranging from "never" to "very often." The total score ranges from 0 to 56, with higher scores indicating greater levels of perceived emotional stress.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Bruxism Awareness as a Pre-Treatment Consideration in Dental Implantology

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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