Menstrual Cycle Effects on Postoperative Sensitivity and Rebound Pain in Composite Restorations

NCT06886243 | Completed

• 2 other identifiers: FIRAT-DENTISTRY ADEMGOK-0011919B012224148
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate how different phases of the menstrual cycle affect pain after dental treatments. Specifically, it investigates two types of pain: Postoperative sensitivity (pain felt after the filling procedure), and Rebound pain (pain that begins after the numbness from anesthesia wears off). The study was conducted with 35 women who received two dental fillings at different times in their cycle: once during the menstrual phase and once during the ovulatory phase. A local anesthetic (inferior alveolar nerve block) was used before treatment, and pain was measured using a 0-10 visual scale at several time points after the procedure. The goal of the study is to understand whether hormonal changes during the menstrual cycle can affect pain levels after dental work. This information could help dentists improve pain management strategies for women and personalize treatment timing.

Conditions

Postoperative Sensitivity; Rebound Pain; Menstrual Cycle; Composite Restorations

Outcome Measures

Primary Outcomes (1)

• Postoperative Sensitivity (POS) Score Measured Using Visual Analog Scale (VAS)

  Postoperative sensitivity (POS) is assessed using the Visual Analog Scale (VAS, 0-10). A score of 0 represents no pain/sensitivity, while 10 represents unbearable pain/sensitivity. Clinically significant postoperative sensitivity is defined as VAS ≥4. Measurements are recorded at 24, 48, and 72 hours after the restoration. Description: Postoperative sensitivity (POS) will be evaluated using the Visual Analog Scale (VAS, 0-10), where 0 represents no pain/sensitivity and 10 represents unbearable pain/sensitivity. Sensitivity will be recorded at 24, 48, and 72 hours postoperatively. A VAS score ≥4 will be considered clinically significant.

  Day 1, Day 2, and Day 3 after restoration

Secondary Outcomes (1)

• Rebound Pain (RP) Score Measured Using Visual Analog Scale (VAS)

  Hour 4, Hour 8, and Hour 12 after anesthesia resolution.

Study Arms (2)

Menstrual Phase Group (MPG)

EXPERIMENTAL

Arm 1: Menstrual Phase Group (MPG) Arm Type: Experimental Arm Name: Menstrual Phase Group (MPG) Description: Participants receive a direct posterior composite restoration during the menstrual phase of their cycle. Postoperative sensitivity (POS) and rebound pain (RP) are assessed at multiple time points.

Procedure: Direct Posterior Composite Restoration

Ovulatory Phase Group (OPG)

EXPERIMENTAL

Arm 2: Ovulatory Phase Group (OPG) Arm Type: Experimental Arm Name: Ovulatory Phase Group (OPG) Description: Participants receive a direct posterior composite restoration during the ovulatory phase of their cycle. POS and RP are assessed at multiple time points.

Procedure: Direct Posterior Composite Restoration

Interventions

Direct Posterior Composite Restoration PROCEDURE

Description: Composite restorations performed using Clearfil Majesty Posterior (Kuraray, Japan) and Clearfil Universal Bond Quick (Kuraray, Japan) in self-etch mode. Inferior alveolar nerve block (IANB) administered with articaine hydrochloride with epinephrine (1:100,000) (Maxicaine).

Menstrual Phase Group (MPG); Ovulatory Phase Group (OPG)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Eligibility is limited based on biological sex due to menstrual cycle-related variables
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants aged 18-45 years
• Regular naturally occurring menstrual cycles (26-32 days)
• No use of hormonal contraceptives
• Good general health
• Vital posterior molar teeth requiring direct composite restorations
• Good oral hygiene and periodontal health

You may not qualify if:

• Irregular menstrual cycles or known hormonal disorders
• Presence of dentin hypersensitivity in the affected tooth
• Regular use of psychiatric or other medications
• History of bruxism, temporomandibular disorders (TMD), or chronic pain syndromes Pregnancy or lactation
• Use of analgesics, oral contraceptives, or anti-inflammatory drugs within 48 hours before treatment
• Severe periodontal disease, dental pain, or need for endodontic treatment

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Firat University Faculty of Dentistry

Elâzığ, 23200, Turkey (Türkiye)

Location

Related Publications (1)

• Eshghpour M, Rezaei NM, Nejat A. Effect of menstrual cycle on frequency of alveolar osteitis in women undergoing surgical removal of mandibular third molar: a single-blind randomized clinical trial. J Oral Maxillofac Surg. 2013 Sep;71(9):1484-9. doi: 10.1016/j.joms.2013.05.004. Epub 2013 Jul 15.

  PMID: 23866782 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the operator performing the restorations and the researcher assessing postoperative sensitivity and rebound pain were blinded to the menstrual cycle phases of the participants.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDs, PhD, Assistant Professor

Model Details: This study is designed as a double-blind, split-mouth, randomized clinical trial. Each participant undergoes two direct posterior composite restorations in different menstrual cycle phases.

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 20, 2025
• Study Start: August 1, 2022
• Primary Completion: February 20, 2023
• Study Completion: June 30, 2023
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)