NCT07719686

Brief Summary

This study evaluates the effect of menstrual cycle phases on pain perception and dental anxiety during non-surgical periodontal therapy in premenopausal women with Stage II and III periodontitis. Pain and anxiety levels were assessed using VAS and DAS scales in perimenstrual and postmenstrual phases. Periodontal treatment outcomes were also recorded before and after therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

July 2, 2026

Last Update Submit

July 20, 2026

Conditions

Keywords

Non-surgical periodontal treatmentDental AnxietyPain PerceptionMenstrual cycle

Outcome Measures

Primary Outcomes (2)

  • Pain perception

    Pain perception during non-surgical periodontal therapy assessed using the Visual Analog Scale (VAS; score range: 0-10), where higher scores indicate greater pain intensity, across menstrual cycle phases.

    Immediately after completion of each treatment session (session duration was not fixed and varied according to the extent of treatment required)

  • Dental Anxiety

    Dental anxiety during non-surgical periodontal therapy was assessed using the Corah Dental Anxiety Scale (DAS; score range: 4-20). The scale consists of four questions related to different dental treatment situations, each with five response options of increasing intensity. Participants were asked to select the response that best reflected their level of anxiety. Higher scores indicate greater anxiety levels, across menstrual cycle phases.

    Immediately after completion of each treatment session (session duration was not fixed and varied according to the extent of treatment required)

Secondary Outcomes (5)

  • Probing Pocket Depth (PPD)

    Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy

  • Clinical Attachment Level (CAL)

    Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy

  • Gingival Index (GI)

    Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy

  • Plaque Index (PI)

    Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy

  • Bleeding on Probing (BoP)

    Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy

Study Arms (2)

Perimenstrual Phase Group

Female patients with Stage II and III periodontitis who underwent non-surgical periodontal therapy during the perimenstrual phase.

Procedure: Non Surgical Periodontal Treatment

Postmenstrual Phase Group

Female patients with Stage II and III periodontitis who underwent non-surgical periodontal therapy during the postmenstrual phase.

Procedure: Non Surgical Periodontal Treatment

Interventions

Standard non-surgical periodontal therapy including scaling and root planing performed without local anesthesia.

Perimenstrual Phase GroupPostmenstrual Phase Group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Systemically healthy premenopausal female patients diagnosed with Stage II and III periodontitis attending the Department of Periodontology were included in the study.

You may qualify if:

  • Female patients aged 18 years and older diagnosed with Stage II and III periodontitis, systemically healthy, and not using medications affecting pain perception or hormonal status. Participants with regular menstrual cycles were included.

You may not qualify if:

  • Patients with systemic diseases, pregnancy or lactation, use of analgesic, anti-inflammatory or hormonal medications, smokers (if excluded), and those with irregular menstrual cycles were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University Faculty of Dentistry, Department of Periodontology

Trabzon, Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, Department of Periodontology

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 22, 2026

Study Start

June 1, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to patient confidentiality and privacy considerations. Data may contain sensitive clinical and personal health information. Therefore, access to the dataset will be restricted to the study investigators only.

Locations