Postoperative Pain After Endodontic TreatmentNCT07173699
Evaluation of the Effect of Salivary Melatonin Levels on Postoperative Pain and Sleep Quality Following Endodontic Treatments Performed at Different Days and Times
A study testing root canal treatment in people with Postoperative Pain After Endodontic Treatment, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Postoperative Pain After Endodontic Treatment
- What is being tested?
- root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 20 Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Faculty of Dentistry, Department of Endodontics
Erzurum, 25240
About this study
Official title: Evaluation of the Effect of Salivary Melatonin Levels on Postoperative Pain and Sleep Quality Following Endodontic Treatments Performed at Different Times of Day
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.
Read the 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.
- Being tested
- root canal treatment
- Keywords
- Root Canal Treatment; Salivary Melatonin; Circadian Rhythm; Postoperative Pain; Sleep Quality
- Medical subject headings
- Pain, Postoperative, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 7 days after each root canal treatment session
Secondary outcomes (1)
Sleep quality
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).
Measured: Within 7 days after each root canal treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Sep 2025
- Primary completion20 Apr 2026 (estimated)
- Study completion20 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain After Endodontic TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KEZBAN MELTEM ÇOLAK, Ataturk University
- Investigators
- KEZBAN MELTEM COLAK, PROF., Principal investigator, Atatürk University, Faculty of Dentistry, Department of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173699
- Sponsor's protocol ID
- ATU-ENDO-MELATONIN-2025
- Status last verified
- Aug 2025
- First submitted
- 8 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this is a single-center academic thesis study with a limited number of patients. Data include personal health information, and sharing outside the study team is restricted due to ethical and confidentiality considerations.
Publications
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.
PubMed 18350967Segura-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.
PubMed 19467050