PeriodontitisMAPPNCT07719686
Effect of Menstrual Cycle Phase on Pain Perception and Anxiety During Non-Surgical Periodontal Treatment
An observational study of Periodontitis, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Periodontitis
- What is being tested?
- Non Surgical Periodontal Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 May 2025
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Systemically healthy premenopausal female patients diagnosed with Stage II and III periodontitis attending the Department of Periodontology were included in the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University Faculty of Dentistry, Department of Periodontology
Trabzon, Trabzon, 61080
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- Non Surgical Periodontal Treatment
- Keywords
- Non-surgical periodontal treatment, Dental Anxiety, Pain Perception, Menstrual cycle
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Surgical Periodontal TreatmentProcedure or surgery
Standard non-surgical periodontal therapy including scaling and root planing performed without local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Perimenstrual Phase Group | Female patients with Stage II and III periodontitis who underwent non-surgical periodontal therapy during the perimenstrual phase. Receives: 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. Receives: Procedure: Non Surgical Periodontal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
PPD was measured in millimeters at six sites per tooth using a periodontal probe, and mean values were calculated per participant.
Measured: Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy
Clinical Attachment Level (CAL)
CAL was measured in millimeters at six sites per tooth using a periodontal probe, and mean values were calculated per participant.
Measured: Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy
Gingival Index (GI)
GI was assessed at four sites per tooth to evaluate gingival inflammation, and mean scores were calculated per participant.
Measured: Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy
Plaque Index (PI)
PI was assessed at four sites per tooth to evaluate plaque accumulation, and mean scores were calculated per participant.
Measured: Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy
Bleeding on Probing (BoP)
BoP was recorded as the percentage of sites showing bleeding within 10 seconds after probing.
Measured: Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Jun 2024
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Nur Kabasakal, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719686
- Sponsor's protocol ID
- KTU-DENT-SK-01
- Acronym
- MAPP
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07719686
- Acronym / sponsor ID
- MAPP / KTU-DENT-SK-01
- Conditions
- Periodontitis
- Keywords
- Non-surgical periodontal treatment, Dental Anxiety, Pain Perception, Menstrual cycle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perimenstrual Phase Group | – | Procedure: Non Surgical Periodontal TreatmentFemale patients with Stage II and III periodontitis who underwent non-surgical periodontal therapy during the perimenstrual phase. |
| Postmenstrual Phase Group | – | Procedure: Non Surgical Periodontal TreatmentFemale patients with Stage II and III periodontitis who underwent non-surgical periodontal therapy during the postmenstrual phase. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Systemically healthy premenopausal female patients diagnosed with Stage II and III periodontitis attending the Department of Periodontology were included in the study.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Surgical Periodontal TreatmentStandard non-surgical periodontal therapy including scaling and root planing performed without local anesthesia. | Procedure or surgery | Perimenstrual Phase Group, Postmenstrual Phase Group |
Primary outcome
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.
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.
5 secondary outcomes
Probing Pocket Depth (PPD)
Time frame: 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
Gingival Index (GI)
Time frame: 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
Bleeding on Probing (BoP)
Time frame: Baseline (pre-treatment) and 6 weeks after completion of non-surgical periodontal therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.