Effect of Menstrual Cycle Phase on Pain Perception and Anxiety During Non-Surgical Periodontal Treatment (MAPP)
20 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
36
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Trabzon
-
Trabzon, Trabzon, Turkije (Türkiye), 61080
- Karadeniz Technical University Faculty of Dentistry, Department of Periodontology
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Systemically healthy premenopausal female patients diagnosed with Stage II and III periodontitis attending the Department of Periodontology were included in the study.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Perimenstrual Phase Group
Female patients with Stage II and III periodontitis who underwent non-surgical periodontal therapy during the perimenstrual phase.
|
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.
|
Standard non-surgical periodontal therapy including scaling and root planing performed without local anesthesia.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain perception
Tijdsspanne: 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
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Probing Pocket Depth (PPD)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juni 2024
Primaire voltooiing (Werkelijk)
1 mei 2025
Studie voltooiing (Werkelijk)
1 mei 2025
Studieregistratiedata
Eerst ingediend
2 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
20 juli 2026
Eerst geplaatst (Werkelijk)
22 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
20 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- KTU-DENT-SK-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .