NCT06429917

Brief Summary

This study aims to explore the mechanisms by which periodontal disease affects the bruxers and to assess the impact of subgingival instrumentation on jaw symptoms of probable bruxers among patients with periodontitis .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 21, 2024

Last Update Submit

May 21, 2024

Conditions

Keywords

Inflammation

Outcome Measures

Primary Outcomes (1)

  • Jaw symptoms

    Improvement in frequency and intensity of Jaw Symptoms (pain, unpleasantness, sensitivity, tiredness, tension and stiffness) as perceived by the patient.

    baseline , 2 months , 3 months and 6 months

Secondary Outcomes (4)

  • Bleeding on probing

    baseline , 2 months , 3 months and 6 months

  • Gingival index

    baseline , 2 months , 3 months and 6 months

  • Probing pocket depth

    baseline , 2 months , 3 months and 6 months

  • tooth mobility

    baseline , 2 months , 3 months and 6 months

Study Arms (1)

Periodontitis with bruxism

OTHER

All the participants will undergo subgingival instrumentation with hand scalers, curettes and ultrasonic scaler. Parameters will be recorded at baseline and two, three and six months of time points after subgingival instrumentation.

Other: Subgingival instrumentation

Interventions

All the participants will undergo subgingival instrumentation with hand scalers, curettes and ultrasonic scaler. Parameters will be recorded at baseline and two, three and six months of time points after subgingival instrumentation.

Periodontitis with bruxism

Eligibility Criteria

Age30 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Systemically healthy patients 2. Patient having habit of bruxism diagnosed with periodontitis 3. Age between 30-40 years 4. Minimum 20 teeth present in oral cavity

You may not qualify if:

  • History of systemic disease such as diabetes or autoimmune disease
  • History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs.
  • Pregnant or lactating females.
  • Post-menopausal women.
  • Patients diagnosed with temporomandibular disorders- pain and tenderness in the masticatory muscles
  • Patients receiving interventions for bruxism.
  • History of Psychological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

PeriodontitisBruxismInflammation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth DiseasesHabitsBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • VARSHA KAPOOR, BDS

    PGIDS, ROHTAK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

RAJINDER KR SHARMA, MDS

CONTACT

VARSHA KAPOOR, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2024

First Posted

May 28, 2024

Study Start

August 1, 2024

Primary Completion

August 1, 2025

Study Completion

September 1, 2025

Last Updated

May 28, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations