Postoperative SensitivityNCT06886243
Menstrual Cycle Effects on Postoperative Sensitivity and Rebound Pain in Composite Restorations
A study testing Direct Posterior Composite Restoration in people with Postoperative Sensitivity and Rebound Pain, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate how different phases of the menstrual cycle affect pain after dental treatments. Specifically, it investigates two types of pain: Postoperative sensitivity (pain felt after the filling procedure), and Rebound pain (pain that begins after the numbness from anesthesia wears off). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Sensitivity, Rebound Pain, Menstrual Cycle
- What is being tested?
- Direct Posterior Composite Restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female participants aged 18-45 years
- Regular naturally occurring menstrual cycles (26-32 days)
- No use of hormonal contraceptives
- Good general health
- Vital posterior molar teeth requiring direct composite restorations
- Good oral hygiene and periodontal health
Who cannot join
- Irregular menstrual cycles or known hormonal disorders
- Presence of dentin hypersensitivity in the affected tooth
- Regular use of psychiatric or other medications
- History of bruxism, temporomandibular disorders (TMD), or chronic pain syndromes Pregnancy or lactation
- Use of analgesics, oral contraceptives, or anti-inflammatory drugs within 48 hours before treatment
- Severe periodontal disease, dental pain, or need for endodontic treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Firat University Faculty of Dentistry
Elâzığ, 23200
About this study
Official title: Effect of Menstrual Cycle on Postoperative Sensitivity and Rebound Pain in Posterior Composite Restorations: A Double-Blind Split-Mouth Clinical Study
This study aims to evaluate how different phases of the menstrual cycle affect pain after dental treatments. Specifically, it investigates two types of pain:
Postoperative sensitivity (pain felt after the filling procedure), and Rebound pain (pain that begins after the numbness from anesthesia wears off). The study was conducted with 35 women who received two dental fillings at different times in their cycle: once during the menstrual phase and once during the ovulatory phase.
Read more
A local anesthetic (inferior alveolar nerve block) was used before treatment, and pain was measured using a 0-10 visual scale at several time points after the procedure.
The goal of the study is to understand whether hormonal changes during the menstrual cycle can affect pain levels after dental work. This information could help dentists improve pain management strategies for women and personalize treatment timing.
Read the detailed description
This clinical trial investigates the effect of menstrual cycle phases on postoperative pain perception following direct posterior composite restorations. It addresses the hypothesis that hormonal fluctuations during the menstrual cycle may alter pain thresholds and nociceptive processing, potentially influencing the intensity and timing of postoperative dental pain.
Estrogen and progesterone, the primary hormones involved in the menstrual cycle, have been shown to modulate pain through their effects on the central and peripheral nervous systems, inflammatory mediators, and endogenous opioid pathways. Despite extensive research on hormonal influences in systemic pain, their specific effects on dental pain-particularly postoperative sensitivity and rebound pain-remain understudied.
The study employed a double-blind, split-mouth, randomized clinical design to minimize inter-subject variability and strengthen internal validity. A total of 35 female participants with regular menstrual cycles underwent two posterior Class II composite restorations, one during the menstrual phase (MPG) and one during the ovulatory phase (OPG). Menstrual phases were confirmed using self-reported cycle calendars and mobile tracking applications.
All restorative procedures were standardized and performed under local anesthesia. Composite restorations were completed using Clearfil Majesty Posterior and Clearfil Universal Bond Quick (self-etch mode). An inferior alveolar nerve block (IANB) was administered using articaine hydrochloride with epinephrine (1:100,000).
Pain was assessed using the Visual Analog Scale (VAS, 0-10) at predefined time points to evaluate two types of postoperative discomfort:
Postoperative Sensitivity (POS): assessed on Day 1, Day 2, and Day 3 following the procedure.
Rebound Pain (RP): assessed at Hour 4, Hour 8, and Hour 12 after the resolution of anesthesia.
Statistical analyses were performed using Cochran's Q test and McNemar's test for within-subject comparisons, and Chi-Square or Fisher's Exact Test for between-group differences. Bonferroni correction was applied for multiple comparisons to control type I error, with p < 0.05 considered statistically significant.
This study provides new insights into the chronobiological factors affecting dental pain and contributes to the evidence base for individualized pain management in female dental patients. The findings may support more personalized scheduling of restorative procedures and better prediction of analgesic needs based on menstrual cycle phases.
- Being tested
- Direct Posterior Composite Restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Posterior Composite RestorationProcedure or surgery
Description: Composite restorations performed using Clearfil Majesty Posterior (Kuraray, Japan) and Clearfil Universal Bond Quick (Kuraray, Japan) in self-etch mode.
Inferior alveolar nerve block (IANB) administered with articaine hydrochloride with epinephrine (1:100,000) (Maxicaine).
| Study group | Role | What they receive |
|---|---|---|
| Menstrual Phase Group (MPG) | Experimental | Arm 1: Menstrual Phase Group (MPG) Arm Type: Experimental Arm Name: Menstrual Phase Group (MPG) Description: Participants receive a direct posterior composite restoration during the menstrual phase of their cycle. Postoperative sensitivity (POS) and rebound pain (RP) are assessed at multiple time points. Receives: Procedure: Direct Posterior Composite Restoration |
| Ovulatory Phase Group (OPG) | Experimental | Arm 2: Ovulatory Phase Group (OPG) Arm Type: Experimental Arm Name: Ovulatory Phase Group (OPG) Description: Participants receive a direct posterior composite restoration during the ovulatory phase of their cycle. POS and RP are assessed at multiple time points. Receives: Procedure: Direct Posterior Composite Restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Sensitivity (POS) Score Measured Using Visual Analog Scale (VAS)
Postoperative sensitivity (POS) is assessed using the Visual Analog Scale (VAS, 0-10).
A score of 0 represents no pain/sensitivity, while 10 represents unbearable pain/sensitivity.
Clinically significant postoperative sensitivity is defined as VAS ≥4. Measurements are recorded at 24, 48, and 72 hours after the restoration. Description: Postoperative sensitivity (POS) will be evaluated using the Visual Analog Scale (VAS, 0-10), where 0 represents no pain/sensitivity and 10 represents unbearable pain/sensitivity. Sensitivity will be recorded at 24, 48, and 72 hours postoperatively. A VAS score ≥4 will be considered clinically significant.
Measured: Day 1, Day 2, and Day 3 after restoration
Secondary outcomes (1)
Rebound Pain (RP) Score Measured Using Visual Analog Scale (VAS)
Rebound pain (RP) is assessed using the Visual Analog Scale (VAS, 0-10) at predefined intervals after the anesthetic effect resolves.
A score of 0 represents no pain, while 10 represents the worst pain experienced.
Clinically significant rebound pain is defined as VAS ≥4. Measurements are recorded at 4, 8, and 12 hours postoperatively after anesthesia resolution.
Measured: Hour 4, Hour 8, and Hour 12 after anesthesia resolution.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Aug 2022
- Primary completion20 Feb 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative SensitivityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is designed as a double-blind, split-mouth, randomized clinical trial. Each participant undergoes two direct posterior composite restorations in different menstrual cycle phases.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adem GOK, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886243
- Sponsor's protocol ID
- FIRAT-DENTISTRY ADEMGOK-001
- Other IDs
- 1919B012224148
- Status last verified
- Mar 2025
- First submitted
- 9 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to share individual participant data.
Publications
Eshghpour M, Rezaei NM, Nejat A. Effect of menstrual cycle on frequency of alveolar osteitis in women undergoing surgical removal of mandibular third molar: a single-blind randomized clinical trial. J Oral Maxillofac Surg. 2013 Sep;71(9):1484-9. doi: 10.1016/j.joms.2013.05.004. Epub 2013 Jul 15.
PubMed 23866782
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Menstrual Cycle on Postoperative Sensitivity and Rebound Pain in Posterior Composite Restorations: A Double-Blind Split-Mouth Clinical Study
- ClinicalTrials.gov ID
- NCT06886243
- Acronym / sponsor ID
- FIRAT-DENTISTRY ADEMGOK-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate how different phases of the menstrual cycle affect pain after dental treatments. Specifically, it investigates two types of pain:
Postoperative sensitivity (pain felt after the filling procedure), and Rebound pain (pain that begins after the numbness from anesthesia wears off). The study was conducted with 35 women who received two dental fillings at different times in their cycle: once during the menstrual phase and once during the ovulatory phase.
A local anesthetic (inferior alveolar nerve block) was used before treatment, and pain was measured using a 0-10 visual scale at several time points after the procedure.
The goal of the study is to understand whether hormonal changes during the menstrual cycle can affect pain levels after dental work. This information could help dentists improve pain management strategies for women and personalize treatment timing.
Detailed description
This clinical trial investigates the effect of menstrual cycle phases on postoperative pain perception following direct posterior composite restorations. It addresses the hypothesis that hormonal fluctuations during the menstrual cycle may alter pain thresholds and nociceptive processing, potentially influencing the intensity and timing of postoperative dental pain.
Estrogen and progesterone, the primary hormones involved in the menstrual cycle, have been shown to modulate pain through their effects on the central and peripheral nervous systems, inflammatory mediators, and endogenous opioid pathways. Despite extensive research on hormonal influences in systemic pain, their specific effects on dental pain-particularly postoperative sensitivity and rebound pain-remain understudied.
The study employed a double-blind, split-mouth, randomized clinical design to minimize inter-subject variability and strengthen internal validity. A total of 35 female participants with regular menstrual cycles underwent two posterior Class II composite restorations, one during the menstrual phase (MPG) and one during the ovulatory phase (OPG). Menstrual phases were confirmed using self-reported cycle calendars and mobile tracking applications.
All restorative procedures were standardized and performed under local anesthesia. Composite restorations were completed using Clearfil Majesty Posterior and Clearfil Universal Bond Quick (self-etch mode). An inferior alveolar nerve block (IANB) was administered using articaine hydrochloride with epinephrine (1:100,000).
Pain was assessed using the Visual Analog Scale (VAS, 0-10) at predefined time points to evaluate two types of postoperative discomfort:
Postoperative Sensitivity (POS): assessed on Day 1, Day 2, and Day 3 following the procedure.
Rebound Pain (RP): assessed at Hour 4, Hour 8, and Hour 12 after the resolution of anesthesia.
Statistical analyses were performed using Cochran's Q test and McNemar's test for within-subject comparisons, and Chi-Square or Fisher's Exact Test for between-group differences. Bonferroni correction was applied for multiple comparisons to control type I error, with p < 0.05 considered statistically significant.
This study provides new insights into the chronobiological factors affecting dental pain and contributes to the evidence base for individualized pain management in female dental patients. The findings may support more personalized scheduling of restorative procedures and better prediction of analgesic needs based on menstrual cycle phases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a double-blind, split-mouth, randomized clinical trial. Each participant undergoes two direct posterior composite restorations in different menstrual cycle phases.
| Arm | Type | Receives |
|---|---|---|
| Menstrual Phase Group (MPG) | Experimental | Procedure: Direct Posterior Composite RestorationArm 1: Menstrual Phase Group (MPG) Arm Type: Experimental Arm Name: Menstrual Phase Group (MPG) Description: Participants receive a direct posterior composite restoration during the menstrual phase of their cycle. Postoperative sensitivity (POS) and rebound pain (RP) are assessed at multiple time points. |
| Ovulatory Phase Group (OPG) | Experimental | Procedure: Direct Posterior Composite RestorationArm 2: Ovulatory Phase Group (OPG) Arm Type: Experimental Arm Name: Ovulatory Phase Group (OPG) Description: Participants receive a direct posterior composite restoration during the ovulatory phase of their cycle. POS and RP are assessed at multiple time points. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female participants aged 18-45 years
- Regular naturally occurring menstrual cycles (26-32 days)
- No use of hormonal contraceptives
- Good general health
- Vital posterior molar teeth requiring direct composite restorations
Key exclusion criteria (6 listed)
- Irregular menstrual cycles or known hormonal disorders
- Presence of dentin hypersensitivity in the affected tooth
- Regular use of psychiatric or other medications
- History of bruxism, temporomandibular disorders (TMD), or chronic pain syndromes Pregnancy or lactation
- Use of analgesics, oral contraceptives, or anti-inflammatory drugs within 48 hours before treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Posterior Composite RestorationDescription: Composite restorations performed using Clearfil Majesty Posterior (Kuraray, Japan) and Clearfil Universal Bond Quick (Kuraray, Japan) in self-etch mode. Inferior alveolar nerve block (IANB) administered with articaine hydrochloride with epinephrine (1:100,000) (Maxicaine). | Procedure or surgery | Menstrual Phase Group (MPG), Ovulatory Phase Group (OPG) |
Primary outcome
Postoperative Sensitivity (POS) Score Measured Using Visual Analog Scale (VAS)
Time frame: Day 1, Day 2, and Day 3 after restoration
Postoperative sensitivity (POS) is assessed using the Visual Analog Scale (VAS, 0-10). A score of 0 represents no pain/sensitivity, while 10 represents unbearable pain/sensitivity. Clinically significant postoperative sensitivity is defined as VAS ≥4. Measurements are recorded at 24, 48, and 72 hours after the restoration. Description: Postoperative sensitivity (POS) will be evaluated using the Visual Analog Scale (VAS, 0-10), where 0 represents no pain/sensitivity and 10 represents unbearable pain/sensitivity. Sensitivity will be recorded at 24, 48, and 72 hours postoperatively. A VAS score ≥4 will be considered clinically significant.
1 secondary outcome
Rebound Pain (RP) Score Measured Using Visual Analog Scale (VAS)
Time frame: Hour 4, Hour 8, and Hour 12 after anesthesia resolution.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Background: PubMed 23866782Eshghpour M, Rezaei NM, Nejat A. Effect of menstrual cycle on frequency of alveolar osteitis in women undergoing surgical removal of mandibular third molar: a single-blind randomized clinical trial. J Oral Maxillofac Surg. 2013 Sep;71(9):1484-9. doi: 10.1016/j.joms.2013.05.004. Epub 2013 Jul 15.
- Individual participant dataSharing planned: No. This study does not plan to share individual participant data.
Related trials for Postoperative Sensitivity
Not yet recruiting
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations
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High-Sensitivity Troponin T Kinetics and 30-Day Outcomes After Major Abdominal Surgery (TROP-MAS)
Myocardial Infarction (MI), Perioperative Myocardial Injury
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Comparison of Postoperative Sensitivity Following Bulk-Fill and Conventional Incremental Composite Restorations: This Study Will be Proceed at Tertiary Care Hospital of Peshawar
To Compare Post Operative Sensitivity
Active, not recruiting
Effect on Placement Tecnique of Bulkfill Composite
Dental Caries, Dental Restoration Failure
RecruitingObservational study
Diagnosis and Allergen Identification of Perioperative Anaphylaxis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Posterior Composite Restoration in people with Postoperative Sensitivity and Rebound Pain, run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Sensitivity (POS) Score Measured Using Visual Analog Scale (VAS) (time frame: Day 1, Day 2, and Day 3 after restoration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06886243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.