Evaluation of the Effect of Salivary Melatonin Levels on Postoperative Pain and Sleep Quality Following Endodontic Treatments Performed at Different Days and Times

NCT07173699 | Active Not Recruiting

• 1 other identifier: ATU-ENDO-MELATONIN-2025
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study aims to evaluate the effect of salivary melatonin levels on postoperative pain and sleep quality in patients undergoing root canal treatment at different times of the day. Each participant will receive endodontic treatment on two asymptomatic mandibular molars, one in the morning and the other in the afternoon. Pain intensity and sleep quality will be assessed using standard questionnaires, and salivary melatonin levels will be analyzed.

Conditions

Postoperative Pain After Endodontic Treatment

Keywords

Root Canal Treatment; Salivary Melatonin; Circadian Rhythm; Postoperative Pain; Sleep Quality

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity

  Pain intensity will be assessed using a 10-cm Visual Analogue Scale (VAS), where 0 represents "no pain" and 10 represents "worst pain imaginable." Participants will record their pain levels following root canal treatment sessions performed in the morning and afternoon.

  Within 7 days after each root canal treatment session

Secondary Outcomes (1)

• Sleep quality

  Within 7 days after each root canal treatment session

Study Arms (2)

Arm 1: Morning Arm

EXPERIMENTAL

Root canal treatment performed on an asymptomatic mandibular molar in the morning session (08:30-09:30). Standard endodontic protocol will be applied. Saliva samples will be collected before the procedure for melatonin analysis, and postoperative pain and sleep quality will be assessed.

Procedure: root canal treatment

Arm 2: Afternoon Arm

EXPERIMENTAL

Root canal treatment performed on an asymptomatic mandibular molar in the afternoon session (14:00-15:00). Standard endodontic protocol will be applied. Saliva samples will be collected before the procedure for melatonin analysis, and postoperative pain and sleep quality will be assessed.

Procedure: root canal treatment

Interventions

root canal treatment PROCEDURE

Standardized root canal treatment performed on asymptomatic mandibular molars. Procedures include local anesthesia, rubber dam isolation, access cavity preparation, cleaning and shaping with rotary instruments, irrigation with NaOCl and EDTA, and obturation using a standardized protocol. Saliva samples are collected prior to treatment for melatonin analysis. Postoperative pain and sleep quality are assessed using validated questionnaires.

Arm 1: Morning Arm; Arm 2: Afternoon Arm

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 25-45 years Patients with two asymptomatic, devital mandibular molars in the same arch No radiographic evidence of periapical lesions or pathological formations in the teeth Patients without systemic diseases (ASA I) Patients who have not used antibiotics, analgesics, or melatonin-containing medications within the last week Patients who have signed the informed consent form

You may not qualify if:

• Patients with a diagnosis of sleep disorder or those regularly using sleep medications/sedatives Patients with systemic diseases (e.g., hypertension, diabetes, endocrine disorders, etc.) Patients receiving psychiatric treatment Pregnant or breastfeeding patients Patients unable to cooperate during the treatment process Patients with restorative or periodontal complications in their teeth Patients working in a shift system

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University Faculty of Dentistry, Department of Endodontics

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (2)

• Benloucif S, Burgess HJ, Klerman EB, Lewy AJ, Middleton B, Murphy PJ, Parry BL, Revell VL. Measuring melatonin in humans. J Clin Sleep Med. 2008 Feb 15;4(1):66-9.

  PMID: 18350967 BACKGROUND

• Segura-Egea JJ, Cisneros-Cabello R, Llamas-Carreras JM, Velasco-Ortega E. Pain associated with root canal treatment. Int Endod J. 2009 Jul;42(7):614-20. doi: 10.1111/j.1365-2591.2009.01562.x. Epub 2009 May 8.

  PMID: 19467050 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• KEZBAN MELTEM COLAK, PROF.

  Atatürk University, Faculty of Dentistry, Department of Endodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study; both participants and investigators are aware of the timing of the intervention.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: KEZBAN MELTEM COLAK

Model Details: Split-mouth crossover design: Each participant will receive root canal treatment on two asymptomatic mandibular molars, one in the morning session and the other in the afternoon session, with a one-week interval.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: September 1, 2025
• Primary Completion: April 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)