Effect of Menstrual Cycle on Postoperative Sensitivity and Rebound Pain in Posterior Composite Restorations: A Double-Blind Split-Mouth Clinical Study
Phase: NA
Conditions: Postoperative Sensitivity, Rebound Pain, Menstrual Cycle, Composite Restorations
Sponsor: Firat University

STUDY PROTOCOL 
 
Official Title: Effect of Menstrual Cycle on Postoperative Sensitivity and Rebound Pain in 
Posterior Composite Restorations: A Double-Blind Split-Mouth Clinical Study 
Unique Protocol ID: FIRAT-DENTISTRY ADEMGOK-001 
NCT ID: …..  
Date: 01.09.2022 
Principal Investigator: Adem GÖK, DDs, PhD, Assistant Professor 
Affiliation: Firat University, Faculty of Dentistry, Department of Restorative Dentistry, 
Elazig, Turkey 
 
📧 mail agok@firat.edu.tr  
📞 Phone: +905444142458 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Objectives: 
 
Primary Objective: To evaluate the effect of menstrual cycle phases on postoperative 
sensitivity (POS) following direct posterior composite restorations. 
 
 
 
Secondary Objective: To assess whether menstrual cycle phases influence the 
incidence or severity of rebound pain (RP) after inferior alveolar nerve block (IANB). 
Study Design: 
 
Type: Double-blind, split-mouth, randomized clinical trial 
 
Study Groups:  
o Menstrual Phase Group (MPG): Restorations performed during days 1-3 of 
menstruation. 
o Ovulatory Phase Group (OPG): Restorations performed on days 11-16, 
depending on cycle length. 
 
Number of Participants: 35 women, each receiving two restorations  
 
Total: 70 restorations). 
 
Masking(Blinding):  
o The operator performing the restorations and the researcher assessing the 
outcomes were blinded to menstrual cycle phases. 
Eligibility Criteria: 
Inclusion Criteria: 
 
Women aged 18-45 years 
 
Regular menstrual cycles (26-32 days) 
 
No hormonal contraceptive use 
 
Vital posterior mandibular molar teeth requiring restorative treatment 
 
Good oral and periodontal health 
Exclusion Criteria: 
 
Irregular menstrual cycles or hormonal disorders 
 
Pregnancy or lactation 
 
Use of analgesics or anti-inflammatory drugs within 48 hours before treatment 
 
Severe periodontal disease or need for endodontic treatment 
Interventions & Procedures: 
 
Anesthesia: Inferior alveolar nerve block (IANB) with articaine hydrochloride with 
epinephrine (1:100,000) 
 
Restorative Material: Clearfil Universal Bond Quick (Kuraray, Japan)  and Clearfil 
Majesty Posterior (Kuraray, Japan) .  
 
Postoperative Sensitivity (POS) Assessment:  
o VAS (0-10) measured at Day 1, Day 2, and Day 3 after restoration. 
 
Rebound Pain (RP) Assessment:  
o VAS (0-10) measured at Hour 4, Hour 8, and Hour 12 after anesthesia 
resolution. 

 
Statistical Analysis: 
 
Cochran’s Q test for intragroup comparisons 
 
McNemar’s test for post-hoc analysis 
 
Chi-Square test or Fisher’s Exact Test for intergroup comparisons 
 
Bonferroni correction for multiple comparisons 
 
Significance Level: p < 0.05 
Ethical Approval: 
 
Non-Interventional Research Ethics Committee of Firat University  
 
Reference No: 2022/08-07 
 
ClinicalTrials.gov Registration No: has not been created yet 
Date of creation: 01.09.2022