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NCT Number: NCT07173699

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University Faculty of Dentistry, Department of Endodontics

Erzurum, 25240, Turkey (Türkiye)

About this study

Postoperative pain following endodontic treatment is a common clinical problem that adversely affects patients' quality of life. Studies have shown that this pain may not only be associated with local tissue trauma and inflammation but can also vary depending on the individual's neuroendocrine system and biological clock (Alhassani & AlGhamdi, 2021).

Many physiological processes in the human body are regulated by the circadian rhythm, which directly influences pain perception, inflammatory responses, and hormone secretion (Smolensky et al., 2015). One of the primary regulatory hormones of circadian rhythm is melatonin, which is secreted mainly by the pineal gland as well as other tissues, reaching peak levels particularly during nighttime. Melatonin is known for its analgesic, anti-inflammatory, antiproliferative, and immunomodulatory properties (Reiter et al., 2010).

In recent years, the effects of melatonin in dentistry have been investigated in the contexts of periodontal regeneration, oral mucosal healing, and bone regeneration (Cutando et al., 2007; Dominguez-Rodriguez et al., 2010). However, clinical studies exploring the role of melatonin during endodontic treatment and its influence on postoperative pain remain very limited. Similarly, no studies in the literature have specifically examined the relationship between melatonin levels and sleep quality in the context of endodontic therapy.

Moreover, some research suggests that dental procedures performed at different times of the day may have varying effects on postoperative pain intensity and the healing process (Segura-Egea et al., 2008). In this regard, understanding how endodontic treatment interacts with systemic biological processes when performed at different times of day is clinically significant.

This study will analyze salivary melatonin levels obtained prior to morning and afternoon endodontic procedures performed on the same patient and will subsequently evaluate their relationship with postoperative pain levels and sleep quality. In doing so, it will provide some of the first clinical evidence regarding the impact of circadian rhythm and melatonin on pain and sleep following endodontic treatment.

In this way, the study not only offers an original approach that may guide clinical practice but also has the potential to lay the groundwork for a personalized dental treatment concept aligned with biological rhythms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Postoperative pain intensity

    Time frame: Within 7 days after each root canal treatment session

    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.

Secondary outcomes

  1. Sleep quality

    Time frame: Within 7 days after each root canal treatment session

    Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). The PSQI measures subjective sleep quality over the past month, but in this study, patients will complete it for the week following each root canal treatment session (morning and afternoon).

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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