Effect of Menstrual Cycle Phase on Pain Perception and Anxiety During Non-Surgical Periodontal Treatment (MAPP)

July 20, 2026 updated by: Seda Nur Kabasakal, Karadeniz Technical University

Comparison of Pain Perception and Anxiety Levels During Non-Surgical Periodontal Treatment in Female Patients With Stage II and III Periodontitis at Different Phases of the Menstrual Cycle

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study investigated the influence of menstrual cycle phases on pain perception and anxiety levels during non-surgical periodontal therapy (NSPT) in systemically healthy premenopausal women diagnosed with Stage II and III periodontitis. A total of 36 participants were included. Clinical periodontal parameters, including probing pocket depth (PPD), clinical attachment level (CAL), gingival index (GI), plaque index (PI), and bleeding on probing (BoP), were recorded before and after NSPT. Pain perception was assessed using the Visual Analog Scale (VAS), and dental anxiety was evaluated using the Corah Dental Anxiety Scale (DAS). NSPT was performed without local anesthesia using a split-mouth design. Outcomes were compared between perimenstrual and postmenstrual phases.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Trabzon
      • Trabzon, Trabzon, Turkey (Türkiye), 61080
        • Karadeniz Technical University Faculty of Dentistry, Department of Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Standard non-surgical periodontal therapy including scaling and root planing performed without local anesthesia.
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
Standard non-surgical periodontal therapy including scaling and root planing performed without local anesthesia.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain perception
Time Frame: Immediately after completion of each treatment session (session duration was not fixed and varied according to the extent of treatment required)
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
Time Frame: Immediately after completion of each treatment session (session duration was not fixed and varied according to the extent of treatment required)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Probing Pocket Depth (PPD)
Time Frame: Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy
PPD was measured in millimeters at six sites per tooth using a periodontal probe, and mean values were calculated per participant.
Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy
Clinical Attachment Level (CAL)
Time Frame: Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy
CAL was measured in millimeters at six sites per tooth using a periodontal probe, and mean values were calculated per participant.
Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy
Gingival Index (GI)
Time Frame: Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy
GI was assessed at four sites per tooth to evaluate gingival inflammation, and mean scores were calculated per participant.
Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy
Plaque Index (PI)
Time Frame: Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy
PI was assessed at four sites per tooth to evaluate plaque accumulation, and mean scores were calculated per participant.
Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy
Bleeding on Probing (BoP)
Time Frame: Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy
BoP was recorded as the percentage of sites showing bleeding within 10 seconds after probing.
Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karadeniz Technical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KTU-DENT-SK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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