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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07173699
Enrollment
45
Registered
2025-09-15
Start date
2025-09-01
Completion date
2026-07-20
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain After Endodontic Treatment

Keywords

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

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.

Detailed description

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.

Interventions

PROCEDUREroot canal treatment

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.

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

This is an open-label study; both participants and investigators are aware of the timing of the intervention.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain intensityWithin 7 days after each root canal treatment sessionPain 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

MeasureTime frameDescription
Sleep qualityWithin 7 days after each root canal treatment sessionSleep 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026