- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07719686
Effect of Menstrual Cycle Phase on Pain Perception and Anxiety During Non-Surgical Periodontal Treatment (MAPP)
20 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
36
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Trabzon
-
Trabzon, Trabzon, Turquie (Türkiye), 61080
- Karadeniz Technical University Faculty of Dentistry, Department of Periodontology
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Systemically healthy premenopausal female patients diagnosed with Stage II and III periodontitis attending the Department of Periodontology were included in the study.
La 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain perception
Délai: 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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Probing Pocket Depth (PPD)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2024
Achèvement primaire (Réel)
1 mai 2025
Achèvement de l'étude (Réel)
1 mai 2025
Dates d'inscription aux études
Première soumission
2 juillet 2026
Première soumission répondant aux critères de contrôle qualité
20 juillet 2026
Première publication (Réel)
22 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KTU-DENT-SK-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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