- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07719686
Effect of Menstrual Cycle Phase on Pain Perception and Anxiety During Non-Surgical Periodontal Treatment (MAPP)
20 juli 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
36
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Trabzon
-
Trabzon, Trabzon, Turkiet (Türkiye), 61080
- Karadeniz Technical University Faculty of Dentistry, Department of Periodontology
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Systemically healthy premenopausal female patients diagnosed with Stage II and III periodontitis attending the Department of Periodontology were included in the study.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain perception
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Probing Pocket Depth (PPD)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2024
Primärt slutförande (Faktisk)
1 maj 2025
Avslutad studie (Faktisk)
1 maj 2025
Studieregistreringsdatum
Först inskickad
2 juli 2026
Först inskickad som uppfyllde QC-kriterierna
20 juli 2026
Första postat (Faktisk)
22 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KTU-DENT-SK-01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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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