Post Operative Pain After Root Canal TherapyPhase 2NCT06975761
Postoperative Pain Comparison of Two Root Canal Sealers in Irreversible Pulpitis
A Phase 2 study testing Resin Based sealer and ZnO eugenol based sealers in people with Post Operative Pain After Root Canal Therapy, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
This study, approved by the Institutional Ethics Review Committee, AFID (Annex "A"), will involve 62 eligible patients from the Operative Dentistry Department, Armed Forces Institute of Dentistry. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain After Root Canal Therapy
- What is being tested?
- Resin Based sealer and ZnO eugenol based sealers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Apr 2025to 7 Aug 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Permanent mandibular first molar with irreversible pulpitis without swelling and sinus.
- Patients of male gender between 20-40 years of age.
- Systemically healthy patients with no other co morbidity classified as ASA-I
- Patients who agree to attend for re call appointments and provide a written consent
Who cannot join
- 1. Teeth with calcified canals and previously treated teeth. 2. Mandibular molars with reversible pulpitis. 3. Pregnant and lactating mothers. 4. Patients who are immunocompromised, anxious, mentally ill. 5. Cases of root fracture. 6. Patients who consumed analgesics 12-24 hrs before primary root canal therapy.
- 7. Patients who are allergic to any of the medications being tested.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Armed Forces Institute of Dentistry
Rawalpindi, Punjab Province, 46000
Areeba Maryam, BDS, +923344782776, areebamaryam94@yahoo.com
Maha Ali Mirza, BDS, 00923365605412, mahaalimirza5@gmail.com
About this study
Official title: A COMPARATIVE EVALUATION OF POST-OPERATIVE PAIN AFTER ROOT CANAL THERAPY USING TWO DIFFERENT ENDODONTIC SEALERS IN PATIENTS WITH SYMPTOMATIC IRREVERSIBLE PULPITIS
This study, approved by the Institutional Ethics Review Committee, AFID (Annex "A"), will involve 62 eligible patients from the Operative Dentistry Department, Armed Forces Institute of Dentistry. Patients (and their guardians) will receive a detailed explanation in Urdu, and written informed consent will be obtained (Annex "B").
Study Design:
Read more
Randomized Controlled Trial: Patients will be randomly divided into two equal groups using a scientific random number table.
Inclusion Screening: Includes medical history, clinical examination, periapical radiographs.
Treatment Protocol:
Root canal therapy under local anesthesia with rubber dam isolation.
Working length determined using DentaPort ZX apex locator, confirmed with radiograph.
Instrumentation: ProTaper Universal hand files up to F2 with 5.25% NaOCl irrigation.
Patency confirmed with #10 K-file between each instrument change.
Final flush with 17% EDTA.
Calcium hydroxide used as intracanal medicament for microbial control.
Temporary restoration using Cavit.
Recall and Evaluation: After 1 week, asymptomatic patients (VAS score 0 and dry canals) will be selected for obturation.
Obturating Materials:
Group 1: AD Seal + F2 single cone gutta-percha (Sure Endo). Group 2: Pulp-dent Sealer + F2 single cone gutta-percha (Sure Endo). Sealers will be mixed per manufacturer's instructions, applied using lentulospiral. The apical extent of the master cone will be confirmed radiographically.
All procedures will be carried out by a single operator. Final restoration will be done using composite, and patients will be referred for full coverage crowns.
Post-Treatment Pain Assessment:Patients will receive a pain diary with a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (severe pain).
Pain will be recorded at 24 hours, 72 hours, and 7 days post-treatment. Analgesic use (type and quantity) will also be noted. Diaries will be collected at the follow-up visit.
Read the detailed description
Study will be conducted after the approval of Institutional Ethics Review Committee, AFID (ANX "A").
A total of 62 entitled patients reporting to Operative Dentistry Department, Armed Forces Institute of Dentistry will be invited for participation in this study. The procedure will be explained to the patients and their parents in Urdu language and a written informed consent will be taken (ANX "B") Patients will be randomly divided into two equal groups with the help of scientific random number table. They will be screened for inclusion by taking history, performing relevant clinical examination and necessary tests along with peri-apical radiographs. Root canal therapy will be then be initiated under local anaesthesia and rubber dam isolation. Working length will be taken 1mm short of radiographic apex with apex locator (Denta Port ZX) and will be confirmed with radiograph. The root canals will be instrumented with ProTaper Universal hand files (dentsply sirona) under copious irrigation with 5.25% sodium hypochlorite (NaOCl) (vista dental products) up to F2 protaper file(dentsply,sirona) . Patency will be confirmed with a #10 K file (dentsply maillefer) between each instrument change. The root canals will be flushed with of 17% EDTA solution (techno dent edetect gel). To control the microbiological impact on post-operative pain calcium hydroxide will be used as an intra-canal medicament and likewise 5.25% sodium hypochlorite as an irrigant in both groups.
After chemomechanical preparation the canals will be dried using sterile paper points (sure endo) and freshly mixed calcium hydroxide paste will be placed into the prepared canals using a lentulospiral (MAN.inc) which is followed by temparory restoration, cavit (provis). The patients will be recalled after a week and patients who will be asymptomatic exhibiting a VAS Score of 0 and dry canals on evaluation with sterile paper points after removal of the intracanal medicament will be obturated. The teeth will be obturated according to the randomly allocated groups, Group 1: endodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation).
Group 2: endodontic sealer pulp-dent sealer and core obturating material single cone F2 gutta parcha. (Bio GP points-sure endo, sure dent cooperation).
Manufacturer's instructions will be followed for mixing the respective sealer on a sterile glass slab. The apical extent of the master cone will be confirmed radiographically. The canals will be coated with the sealer using lentulospiral (MAN,Inc.) in a slow speed hand piece followed by the obturation of canals with single cone F2 gutta parcha (Bio GP points-sure endo, sure dent cooperation).
All the clinical procedures will be performed by single operator. After obturation access cavity is restored with composite and the patient will be refered to prosthodontic department for the provision of full coverage crowns.
Post-treatment pain assessment:
After obturation and restoration with composite all the patients will handed over a pain diary form with visual analogue scale (VAS) consisting of a 10 cm line divided into 10 equal parts from 0 indicating no pain to 10 indicating extremely severe pain. This provided a range of score from 0-10. The patients will be asked to record their pain response at 24 hrs, 72 h and 7 days after therapy followed by which the patients will be recalled to give the diary to the investigators on their follow up visit. In case of consumption of analgesics, the type and quantity after treatment will also be recorded.
- Being tested
- Resin Based sealer, ZnO eugenol based sealers
- Keywords
- post operative pain, irreversible pulpitis, endodontic sealers
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin Based sealerDrug
Post-operative pain after Root Canal Therapy by using resin based sealer
ZnO eugenol based sealersDrug
Post-operative pain after Root Canal Therapy by using ZnO eugenol based sealer
| Study group | Role | What they receive |
|---|---|---|
| Resin based sealer | Active comparator | Endodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation) Receives: Drug: Resin Based sealer |
| ZnO eugenol based sealer | Active comparator | Endodontic sealer pulp-dent sealer and core obturating material single cone F2 gutta parcha. (Bio GP points-sure endo, sure dent cooperation) Receives: Drug: ZnO eugenol based sealers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative pain by using resin based sealer on visual analogue scale
endodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation),post-operative pain on visual analogue scale.
Measured: 24 hours
Post-Operative pain by using resin based sealer on visual analogue scale
endodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation),post operative pain on visual analogue scale
Measured: 72 hours
Post-Operative pain by using resin based sealer on visual analogue scale
endodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation),post operative pain on visual analogue scale
Measured: 7 days
Post-Operative pain by using ZnO engenol based sealer on visual analogue scale
endodontic sealer pulp-dent sealer and core obturating material single cone F2 gutta parcha. (Bio GP points-sure endo, sure dent cooperation),post-operative pain on visual analogue scale.
Measured: 24 hours
Post-Operative pain by using ZnO engenol based sealer on visual analogue scale
endodontic sealer pulp-dent sealer and core obturating material single cone F2 gutta parcha. (Bio GP points-sure endo, sure dent cooperation),post-operative pain on visual analogue scale
Measured: 72 hours
Post-Operative pain by using ZnO engenol based sealer on visual analogue scale
endodontic sealer pulp-dent sealer and core obturating material single cone F2 gutta parcha. (Bio GP points-sure endo, sure dent cooperation),post-operative pain on visual analogue scale
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start7 Apr 2025
- Primary completion7 Aug 2025 (estimated)
- Study completion7 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain After Root Canal TherapyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Areeba Maryam, Armed Forces Institute of Dentistry, Pakistan
- Investigators
- Areeba Maryam, BDS, Principal investigator, AFID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975761
- Sponsor's protocol ID
- Pulpdent Versus Ad-seal
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A COMPARATIVE EVALUATION OF POST-OPERATIVE PAIN AFTER ROOT CANAL THERAPY USING TWO DIFFERENT ENDODONTIC SEALERS IN PATIENTS WITH SYMPTOMATIC IRREVERSIBLE PULPITIS
- ClinicalTrials.gov ID
- NCT06975761
- Acronym / sponsor ID
- Pulpdent Versus Ad-seal
- Keywords
- post operative pain, irreversible pulpitis, endodontic sealers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 7 Aug 2025 (estimated)
- Study completion
- 7 Aug 2025 (estimated)
- First posted
- 16 May 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, approved by the Institutional Ethics Review Committee, AFID (Annex "A"), will involve 62 eligible patients from the Operative Dentistry Department, Armed Forces Institute of Dentistry. Patients (and their guardians) will receive a detailed explanation in Urdu, and written informed consent will be obtained (Annex "B").
Study Design:
Randomized Controlled Trial: Patients will be randomly divided into two equal groups using a scientific random number table.
Inclusion Screening: Includes medical history, clinical examination, periapical radiographs.
Treatment Protocol:
Root canal therapy under local anesthesia with rubber dam isolation.
Working length determined using DentaPort ZX apex locator, confirmed with radiograph.
Instrumentation: ProTaper Universal hand files up to F2 with 5.25% NaOCl irrigation.
Patency confirmed with #10 K-file between each instrument change.
Final flush with 17% EDTA.
Calcium hydroxide used as intracanal medicament for microbial control.
Temporary restoration using Cavit.
Recall and Evaluation: After 1 week, asymptomatic patients (VAS score 0 and dry canals) will be selected for obturation.
Obturating Materials:
Group 1: AD Seal + F2 single cone gutta-percha (Sure Endo). Group 2: Pulp-dent Sealer + F2 single cone gutta-percha (Sure Endo). Sealers will be mixed per manufacturer's instructions, applied using lentulospiral. The apical extent of the master cone will be confirmed radiographically.
All procedures will be carried out by a single operator. Final restoration will be done using composite, and patients will be referred for full coverage crowns.
Post-Treatment Pain Assessment:Patients will receive a pain diary with a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (severe pain).
Pain will be recorded at 24 hours, 72 hours, and 7 days post-treatment. Analgesic use (type and quantity) will also be noted. Diaries will be collected at the follow-up visit.
Detailed description
Study will be conducted after the approval of Institutional Ethics Review Committee, AFID (ANX "A").
A total of 62 entitled patients reporting to Operative Dentistry Department, Armed Forces Institute of Dentistry will be invited for participation in this study. The procedure will be explained to the patients and their parents in Urdu language and a written informed consent will be taken (ANX "B") Patients will be randomly divided into two equal groups with the help of scientific random number table. They will be screened for inclusion by taking history, performing relevant clinical examination and necessary tests along with peri-apical radiographs. Root canal therapy will be then be initiated under local anaesthesia and rubber dam isolation. Working length will be taken 1mm short of radiographic apex with apex locator (Denta Port ZX) and will be confirmed with radiograph. The root canals will be instrumented with ProTaper Universal hand files (dentsply sirona) under copious irrigation with 5.25% sodium hypochlorite (NaOCl) (vista dental products) up to F2 protaper file(dentsply,sirona) . Patency will be confirmed with a #10 K file (dentsply maillefer) between each instrument change. The root canals will be flushed with of 17% EDTA solution (techno dent edetect gel). To control the microbiological impact on post-operative pain calcium hydroxide will be used as an intra-canal medicament and likewise 5.25% sodium hypochlorite as an irrigant in both groups.
After chemomechanical preparation the canals will be dried using sterile paper points (sure endo) and freshly mixed calcium hydroxide paste will be placed into the prepared canals using a lentulospiral (MAN.inc) which is followed by temparory restoration, cavit (provis). The patients will be recalled after a week and patients who will be asymptomatic exhibiting a VAS Score of 0 and dry canals on evaluation with sterile paper points after removal of the intracanal medicament will be obturated. The teeth will be obturated according to the randomly allocated groups, Group 1: endodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation).
Group 2: endodontic sealer pulp-dent sealer and core obturating material single cone F2 gutta parcha. (Bio GP points-sure endo, sure dent cooperation).
Manufacturer's instructions will be followed for mixing the respective sealer on a sterile glass slab. The apical extent of the master cone will be confirmed radiographically. The canals will be coated with the sealer using lentulospiral (MAN,Inc.) in a slow speed hand piece followed by the obturation of canals with single cone F2 gutta parcha (Bio GP points-sure endo, sure dent cooperation).
All the clinical procedures will be performed by single operator. After obturation access cavity is restored with composite and the patient will be refered to prosthodontic department for the provision of full coverage crowns.
Post-treatment pain assessment:
After obturation and restoration with composite all the patients will handed over a pain diary form with visual analogue scale (VAS) consisting of a 10 cm line divided into 10 equal parts from 0 indicating no pain to 10 indicating extremely severe pain. This provided a range of score from 0-10. The patients will be asked to record their pain response at 24 hrs, 72 h and 7 days after therapy followed by which the patients will be recalled to give the diary to the investigators on their follow up visit. In case of consumption of analgesics, the type and quantity after treatment will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resin based sealer | Active comparator | Drug: Resin Based sealerEndodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation) |
| ZnO eugenol based sealer | Active comparator | Drug: ZnO eugenol based sealersEndodontic sealer pulp-dent sealer and core obturating material single cone F2 gutta parcha. (Bio GP points-sure endo, sure dent cooperation) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Permanent mandibular first molar with irreversible pulpitis without swelling and sinus.
- Patients of male gender between 20-40 years of age.
- Systemically healthy patients with no other co morbidity classified as ASA-I
- Patients who agree to attend for re call appointments and provide a written consent
Key exclusion criteria (2 listed)
- 1. Teeth with calcified canals and previously treated teeth. 2. Mandibular molars with reversible pulpitis. 3. Pregnant and lactating mothers. 4. Patients who are immunocompromised, anxious, mentally ill. 5. Cases of root fracture. 6. Patients who consumed analgesics 12-24 hrs before primary root canal therapy.
- 7. Patients who are allergic to any of the medications being tested.
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 |
|---|---|---|
| Resin Based sealerPost-operative pain after Root Canal Therapy by using resin based sealer | Drug | Resin based sealer |
| ZnO eugenol based sealersPost-operative pain after Root Canal Therapy by using ZnO eugenol based sealer | Drug | ZnO eugenol based sealer |
Primary outcome
Post-Operative pain by using resin based sealer on visual analogue scale
Time frame: 24 hours
endodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation),post-operative pain on visual analogue scale.
Post-Operative pain by using resin based sealer on visual analogue scale
Time frame: 72 hours
endodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation),post operative pain on visual analogue scale
Post-Operative pain by using resin based sealer on visual analogue scale
Time frame: 7 days
endodontic sealer AD seal and core obturating material single cone F2 gutta parcha(Bio GP points-sure endo, sure dent cooperation),post operative pain on visual analogue scale
Post-Operative pain by using ZnO engenol based sealer on visual analogue scale
Time frame: 24 hours
endodontic sealer pulp-dent sealer and core obturating material single cone F2 gutta parcha. (Bio GP points-sure endo, sure dent cooperation),post-operative pain on visual analogue scale.
Post-Operative pain by using ZnO engenol based sealer on visual analogue scale
Time frame: 72 hours
endodontic sealer pulp-dent sealer and core obturating material single cone F2 gutta parcha. (Bio GP points-sure endo, sure dent cooperation),post-operative pain on visual analogue scale
Post-Operative pain by using ZnO engenol based sealer on visual analogue scale
Time frame: 7 days
endodontic sealer pulp-dent sealer and core obturating material single cone F2 gutta parcha. (Bio GP points-sure endo, sure dent cooperation),post-operative pain on visual analogue scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: Undecided
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Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
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Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
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Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
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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.
Areeba Maryam, BDS principal investigator
AFID
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resin Based sealer and ZnO eugenol based sealers in people with Post Operative Pain After Root Canal Therapy, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 16 May 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 Pakistan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Areeba Maryam, BDS (+923344782776, areebamaryam94@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Operative pain by using resin based sealer on visual analogue scale (time frame: 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.