ClinicalTrials.gg
RecruitingNCT06435208Updated Jul 8, 2024

Impact of Subgingival Instrumentation on Psychological Distress and Mental Health Status in Bruxers With Periodontitis

An interventional study of Subgingival instrumentation in Periodontal Diseases, Bruxism and Periodontitis, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Recruiting at 1 site in India. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-08.

Primary conditionPeriodontitisRegistry: Periodontal DiseasesReclassifiedWhy we changed it
Registry
Periodontal Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Periodontitis
Why
  1. The study's listed conditions name Periodontitis, a narrower term within Periodontal Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
30 Years to 50 Years
Sex
All
01

Study summary

Bruxism is a non-functional repetitive jaw-muscle activity characterized by grinding or clenching the teeth. Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism.

Read the detailed description

Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Although the etiology is not known exactly, it has been suggested that bruxism is a multifactorial disorder. Periodontitis, a prevalent inflammatory condition affecting the periodontium, has been linked to bruxism in several studies. The coexistence of bruxism and periodontitis poses unique challenges in clinical management of periodontitis. Also, as periodontitis became chronic, the occurrence of depression increased. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism. Therefore, this study aims to investigate impact of subgingival instrumentation on psychological distress and mental health status in bruxers with periodontitis.

02

Conditions studied

  • Periodontal Diseases
  • Bruxism
  • Periodontitis
  • Distress, Emotional

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03

In context

Periodontitis Reclassified

1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.

This study's planned enrollment of 45 is close to the median of 44 across 846 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak is the lead sponsor of 213 studies on the registry; 72 are open to participants now.

Compared within Periodontitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Periodontal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Systemically healthy patients
  • Patient having periodontitis with bruxism
  • Age between 30-50 years

Exclusion criteria

Exclusion Criteria:

  • History of mental health disorder
  • History of systemic disease
  • History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs
  • Pregnant or lactating females
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    PERIODONTITIS BRUXISM

    subgingival instrumentation will be done in all participants

    Other: Subgingival instrumentation

Interventions

  • OtherSubgingival instrumentation

    All the participants will undergo scaling and root planning with hand scalers, curettes and ultrasonic scaler.

06

What researchers measure

Primary outcomes

  1. Psychological distress

    Assessment of psychological distress will be done by using Kessler Psychological distress(K10)

    Time frame: BASELINE,2 MONTHS ,3 MONTHS

  2. Mental Health Status

    Assessment of mental health status will be done by using mental health inventory 38

    Time frame: Baseline, 2 months, 3 months

Secondary outcomes

  1. periodontal parameter

    periodontal probing depth

    Time frame: Baseline, 2 month, 3 month

  2. periodontal inflammation

    bleeding on probing

    Time frame: Baseline, 2 month, 3 month

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Dec 2024, 4 months after the start.

Of 480 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 4 months is below that.

Counting every sponsor, half of 494 studies reached it within 16 months; a quarter within 8 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
May 17, 2024
First posted
May 30, 2024
StartActual
Jul 4, 2024
Primary completionEst.
Dec 1, 2024
CompletionEst.
Feb 1, 2025
Last update
Jul 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06435208
Responsible party
Sponsor
First posted
May 30, 2024
Start date
Jul 4, 2024
Primary completion
Dec 1, 2024 (estimated)
Completion
Feb 1, 2025 (estimated)
Last update
Jul 8, 2024

Study contacts

RAJINDER KR SHARMA, MDS
Contact
rksharmamds@yahoo.in
9416358222
Priyanka Chandela, BDS
Contact
priyankachandela48@gmail.com
+917027019277
Priyanka Chandela, BDS
principal investigator · PGIDS , ROHTAK

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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