- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07719686
Effect of Menstrual Cycle Phase on Pain Perception and Anxiety During Non-Surgical Periodontal Treatment (MAPP)
20. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Observasjonsmessig
Registrering (Faktiske)
36
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Trabzon
-
Trabzon, Trabzon, Tyrkia (Türkiye), 61080
- Karadeniz Technical University Faculty of Dentistry, Department of Periodontology
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Systemically healthy premenopausal female patients diagnosed with Stage II and III periodontitis attending the Department of Periodontology were included in the study.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain perception
Tidsramme: 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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Probing Pocket Depth (PPD)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2024
Primær fullføring (Faktiske)
1. mai 2025
Studiet fullført (Faktiske)
1. mai 2025
Datoer for studieregistrering
Først innsendt
2. juli 2026
Først innsendt som oppfylte QC-kriteriene
20. juli 2026
Først lagt ut (Faktiske)
22. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KTU-DENT-SK-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .