Post Endodontic PainNCT06632015
Effect of DCS on Post-Endodontic Pain
A study testing Calcium Hydroxide (CH), Diclofenac Sodium (DCS) and Calcium Hydroxide + Diclofenac Sodium (CH + DCS) in people with Post Endodontic Pain, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized, triple-blind, parallel-group clinical trial was to evaluate the effects of calcium hydroxide (CH), diclofenac sodium (DCS), and their combination (CH+DCS) as intracanal medicaments on post-endodontic pain in mandibular molars diagnosed with symptomatic apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Endodontic Pain
- What is being tested?
- Calcium Hydroxide (CH), Diclofenac Sodium (DCS) and Calcium Hydroxide + Diclofenac Sodium (CH + DCS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jan 2024to 24 May 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years
- Systemically healthy (ASA I-II)
- Diagnosed with symptomatic irreversible pulpitis or symptomatic apical periodontitis in mandibular molars (characterized by spontaneous pain or prolonged pain in response to cold test, and presence of percussion sensitivity)
- Positive response to Electric Pulp Testing (EPT) and cold testing
- Periapical Index (PAI) score of 1 or 2 according to Ørstavik et al. (1986)
- Pre-operative pain level ≥50 mm on the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 100 (most severe pain)
Who cannot join
- History of psychiatric disorders
- Allergic reactions
- Pregnancy
- Use of analgesics within the previous 24 hours
- Use of antibiotics within the last 3 months
- Teeth with a sinus tract or history of abscess formation
Show all 10Show fewer
- Periodontal pocket depth >3 mm
- Root resorption, root fractures, or ankylosis
- Previous root canal treatment on the selected tooth
- Teeth requiring prosthetic restoration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Calcium Hydroxide and Diclofenac Sodium on Post-Endodontic Pain: A Double-Blinded, Parallel Group, Randomized Controlled Clinical Trial
The aim of this randomized, triple-blind, parallel-group clinical trial was to evaluate the effects of calcium hydroxide (CH), diclofenac sodium (DCS), and their combination (CH+DCS) as intracanal medicaments on post-endodontic pain in mandibular molars diagnosed with symptomatic apical periodontitis. Ninety patients were randomly assigned to three groups (CH, DCS, or CH+DCS; n=30 each). Pain intensity was recorded using a 100 mm Visual Analog Scale (VAS) over 7 days following treatment, and the number of analgesic tablets taken was also recorded. Statistical analyses were performed using Kruskal-Wallis, Friedman, Wilcoxon signed-rank, and Chi-square tests, with significance set at 0.05. The null hypothesis stated that there would be no significant difference in post-endodontic pain among the groups.
Read the detailed description
This randomized, triple-blind, parallel-group clinical trial included 90 patients aged 18-60 years with a single mandibular molar diagnosed with symptomatic apical periodontitis. Sample size was calculated based on a priori power analysis to detect significant differences in post-endodontic pain, resulting in 30 participants per group.
All endodontic procedures were performed by a single clinician under local anesthesia. After tooth isolation and access cavity preparation, working length was determined using K-files and an apex locator, verified radiographically. Chemomechanical preparation was performed using Reciproc files according to canal dimensions. Irrigation was performed using 2.5% NaOCl and 17% EDTA, followed by canal drying.
Patients were randomly assigned to three groups according to the intracanal medicament:
Group 1 (CH): 1 g Calcium Hydroxide mixed with 1 mL distilled water Group 2 (DCS): 1 g Diclofenac Sodium mixed with 1 mL distilled water Group 3 (CH + DCS): 950 mg Calcium Hydroxide + 50 mg Diclofenac Sodium mixed with 1 mL distilled water The canals were sealed temporarily. Postoperative pain was recorded daily for 7 days using a 100 mm Visual Analog Scale (VAS). Patients also recorded the number of analgesic tablets taken. Pain assessments were conducted by a blinded researcher. For pain management, 400 mg ibuprofen was prescribed if needed, with contact support provided for severe pain.
At the second session, medicaments were removed, final irrigation was performed, canals were dried, and obturation was completed using a single-cone technique with gutta-percha and calcium silicate sealer. Teeth were restored with resin composite.
- Conditions
- Post Endodontic Pain
- Being tested
- Calcium Hydroxide (CH), Diclofenac Sodium (DCS), Calcium Hydroxide + Diclofenac Sodium (CH + DCS)
- Keywords
- Endodontics, Post-Endodontic Pain, Calcium Hydroxide, Diclofenac Sodium, Intracanal Medicament, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxide (CH)Drug
1 mL distilled water mixed with 1 g calcium hydroxide powder, placed into the root canals using a lentulo spiral.
Diclofenac Sodium (DCS)Drug
1 mL distilled water mixed with 1 g diclofenac sodium powder, placed into the root canals using a lentulo spiral.
Calcium Hydroxide + Diclofenac Sodium (CH + DCS)Drug
1 mL distilled water mixed with 950 mg calcium hydroxide powder and 50 mg diclofenac sodium powder, placed into the root canals using a lentulo spiral.
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide (CH) | Experimental | Working length was determined using a size 15 K-file and an apex locator (Morita Root ZX, Tokyo, Japan) and confirmed radiographically. Chemomechanical preparation was performed as described in the protocol. After drying with paper points, 1 mL of distilled water mixed with 1 g calcium hydroxide powder was placed as the intracanal medicament. Receives: Drug: Calcium Hydroxide (CH) |
| Diclofenac Sodium (DCS) | Experimental | Procedures as in Arm 1. After drying with paper points, 1 mL of distilled water mixed with 1 g diclofenac sodium powder was placed as the intracanal medicament. Receives: Drug: Diclofenac Sodium (DCS) |
| Calcium Hydroxide + Diclofenac Sodium (CH+DCS) | Experimental | Procedures as in Arm 1. After drying with paper points, 1 mL of distilled water mixed with 950 mg calcium hydroxide powder and 50 mg diclofenac sodium powder was placed as the intracanal medicament. Receives: Drug: Calcium Hydroxide + Diclofenac Sodium (CH + DCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Endodontic Pain
Pre-operative (before treatment) and post-operative pain were assessed using the Visual Analog Scale (VAS), a 100 mm horizontal line with numerical values. Patients rated their pain on the VAS, and pain severity was categorized as follows: No pain (0 mm), mild pain (1-19 mm), moderate pain (20-49 mm), severe pain (50-79 mm), and very severe pain (80-100 mm). Post-operative pain measurements were taken on Days 1, 2, 3, 4, 5, 6, and 7 after intracanal medicament application.
Measured: Baseline and Days 1-7 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start22 Jan 2024
- Primary completion17 May 2024
- Study completion24 May 2024
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 Post Endodontic PainStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BÜŞRA FİDANOĞLU, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632015
- Sponsor's protocol ID
- HMKU-001
- Status last verified
- Aug 2025
- First submitted
- 7 Oct 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient privacy and confidentiality.
Publications
Fidanoglu B, Tufenkci P, Sari M. The effects of calcium hydroxide and diclofenac sodium as root canal medicaments on post-endodontic pain: a double-blinded, parallel group, randomized controlled clinical trial. Odontology. 2025 Nov 9. doi: 10.1007/s10266-025-01252-9. Online ahead of print.
PubMed 41206809
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Calcium Hydroxide and Diclofenac Sodium on Post-Endodontic Pain: A Double-Blinded, Parallel Group, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06632015
- Acronym / sponsor ID
- HMKU-001
- Conditions
- Post Endodontic Pain
- Keywords
- Endodontics, Post-Endodontic Pain, Calcium Hydroxide, Diclofenac Sodium, Intracanal Medicament, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 8 Oct 2024 (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.
The aim of this randomized, triple-blind, parallel-group clinical trial was to evaluate the effects of calcium hydroxide (CH), diclofenac sodium (DCS), and their combination (CH+DCS) as intracanal medicaments on post-endodontic pain in mandibular molars diagnosed with symptomatic apical periodontitis. Ninety patients were randomly assigned to three groups (CH, DCS, or CH+DCS; n=30 each). Pain intensity was recorded using a 100 mm Visual Analog Scale (VAS) over 7 days following treatment, and the number of analgesic tablets taken was also recorded. Statistical analyses were performed using Kruskal-Wallis, Friedman, Wilcoxon signed-rank, and Chi-square tests, with significance set at 0.05. The null hypothesis stated that there would be no significant difference in post-endodontic pain among the groups.
Detailed description
This randomized, triple-blind, parallel-group clinical trial included 90 patients aged 18-60 years with a single mandibular molar diagnosed with symptomatic apical periodontitis. Sample size was calculated based on a priori power analysis to detect significant differences in post-endodontic pain, resulting in 30 participants per group.
All endodontic procedures were performed by a single clinician under local anesthesia. After tooth isolation and access cavity preparation, working length was determined using K-files and an apex locator, verified radiographically. Chemomechanical preparation was performed using Reciproc files according to canal dimensions. Irrigation was performed using 2.5% NaOCl and 17% EDTA, followed by canal drying.
Patients were randomly assigned to three groups according to the intracanal medicament:
Group 1 (CH): 1 g Calcium Hydroxide mixed with 1 mL distilled water Group 2 (DCS): 1 g Diclofenac Sodium mixed with 1 mL distilled water Group 3 (CH + DCS): 950 mg Calcium Hydroxide + 50 mg Diclofenac Sodium mixed with 1 mL distilled water The canals were sealed temporarily. Postoperative pain was recorded daily for 7 days using a 100 mm Visual Analog Scale (VAS). Patients also recorded the number of analgesic tablets taken. Pain assessments were conducted by a blinded researcher. For pain management, 400 mg ibuprofen was prescribed if needed, with contact support provided for severe pain.
At the second session, medicaments were removed, final irrigation was performed, canals were dried, and obturation was completed using a single-cone technique with gutta-percha and calcium silicate sealer. Teeth were restored with resin composite.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxide (CH) | Experimental | Drug: Calcium Hydroxide (CH)Working length was determined using a size 15 K-file and an apex locator (Morita Root ZX, Tokyo, Japan) and confirmed radiographically. Chemomechanical preparation was performed as described in the protocol. After drying with paper points, 1 mL of distilled water mixed with 1 g calcium hydroxide powder was placed as the intracanal medicament. |
| Diclofenac Sodium (DCS) | Experimental | Drug: Diclofenac Sodium (DCS)Procedures as in Arm 1. After drying with paper points, 1 mL of distilled water mixed with 1 g diclofenac sodium powder was placed as the intracanal medicament. |
| Calcium Hydroxide + Diclofenac Sodium (CH+DCS) | Experimental | Drug: Calcium Hydroxide + Diclofenac Sodium (CH + DCS)Procedures as in Arm 1. After drying with paper points, 1 mL of distilled water mixed with 950 mg calcium hydroxide powder and 50 mg diclofenac sodium powder was placed as the intracanal medicament. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 60 years
- Systemically healthy (ASA I-II)
- Diagnosed with symptomatic irreversible pulpitis or symptomatic apical periodontitis in mandibular molars (characterized by spontaneous pain or prolonged pain in response to cold test, and presence of percussion sensitivity)
- Positive response to Electric Pulp Testing (EPT) and cold testing
- Periapical Index (PAI) score of 1 or 2 according to Ørstavik et al. (1986)
Key exclusion criteria (10 listed)
- History of psychiatric disorders
- Allergic reactions
- Pregnancy
- Use of analgesics within the previous 24 hours
- Use of antibiotics within the last 3 months
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 |
|---|---|---|
| Calcium Hydroxide (CH)1 mL distilled water mixed with 1 g calcium hydroxide powder, placed into the root canals using a lentulo spiral. | Drug | Calcium Hydroxide (CH) |
| Diclofenac Sodium (DCS)1 mL distilled water mixed with 1 g diclofenac sodium powder, placed into the root canals using a lentulo spiral. | Drug | Diclofenac Sodium (DCS) |
| Calcium Hydroxide + Diclofenac Sodium (CH + DCS)1 mL distilled water mixed with 950 mg calcium hydroxide powder and 50 mg diclofenac sodium powder, placed into the root canals using a lentulo spiral. | Drug | Calcium Hydroxide + Diclofenac Sodium (CH+DCS) |
Primary outcome
Post-Endodontic Pain
Time frame: Baseline and Days 1-7 post-treatment
Pre-operative (before treatment) and post-operative pain were assessed using the Visual Analog Scale (VAS), a 100 mm horizontal line with numerical values. Patients rated their pain on the VAS, and pain severity was categorized as follows: No pain (0 mm), mild pain (1-19 mm), moderate pain (20-49 mm), severe pain (50-79 mm), and very severe pain (80-100 mm). Post-operative pain measurements were taken on Days 1, 2, 3, 4, 5, 6, and 7 after intracanal medicament application.
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 22 Aug 2025.
- Derived from this study: PubMed 41206809Fidanoglu B, Tufenkci P, Sari M. The effects of calcium hydroxide and diclofenac sodium as root canal medicaments on post-endodontic pain: a double-blinded, parallel group, randomized controlled clinical trial. Odontology. 2025 Nov 9. doi: 10.1007/s10266-025-01252-9. Online ahead of print.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient privacy and confidentiality.
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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 Calcium Hydroxide (CH), Diclofenac Sodium (DCS) and Calcium Hydroxide + Diclofenac Sodium (CH + DCS) in people with Post Endodontic Pain, run by Mustafa Kemal 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 10 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 22 Aug 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?
Post-Endodontic Pain (time frame: Baseline and Days 1-7 post-treatment). 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 NCT06632015, 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 22 Aug 2025.