Post-operative PainNCT07375576
Outcomes of Pulpotomy and Root Canal Treatment in Teeth With Symptomatic Irreversible Pulpitis
A study testing Total Pulpotomy, Radicular pulpotomy and Root canal treatment in people with Post-operative Pain and Pulpitis - Irreversible, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the clinical effectiveness of total pulpotomy (TP), radicular pulpotomy (RP), and root canal treatment (RCT) in mandibular premolar and/or molar teeth diagnosed with symptomatic irreversible pulpitis, with respect to postoperative pain control and treatment success.Materials and… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Pulpitis - Irreversible, Success Rate
- What is being tested?
- Total Pulpotomy, Radicular pulpotomy and Root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 Aug 2027
- Phase
- Interventional
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy patients of both sexes, aged between 15 and 45 years, with no systemic diseases, will be screened for inclusion in the study. Strict eligibility criteria will be applied.
- The patients included in the study must have restorable, extremely deep carious lesions in the mandibular first and second molars, and first and second premolars; healthy periodontal status (periodontal pocket ≤ 3 mm); and a clinical diagnosis of symptomatic irreversible pulpitis (history of spontaneous pain, pain persisting after removal of the stimulus, exaggerated and prolonged response to cold testing, and a positive response to the electric pulp test).
Who cannot join
- Teeth with cracks or cusp fractures, subgingival caries, or periapical radiolucency will not be included in the study.
- Informed consent will be obtained from all included patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University
Hatay, Antakya, 31000
Efkan Aksay, +905062654889, efkanaksay@gmail.com
Merve Sarı, DDS, +905546430401, sarimerve94@outlook.com
About this study
Official title: Evaluation of the Outcomes of Total Pulpotomy, Radicular Pulpotomy, and Root Canal Treatment in Teeth With Extremely Deep Caries and Symptomatic Irreversible Pulpitis
The aim of this study is to evaluate the clinical effectiveness of total pulpotomy (TP), radicular pulpotomy (RP), and root canal treatment (RCT) in mandibular premolar and/or molar teeth diagnosed with symptomatic irreversible pulpitis, with respect to postoperative pain control and treatment success.Materials and Methods:A total of 99 mandibular premolar and molar teeth will be included in this study. The teeth will be randomly allocated into three groups (n = 33 per group): total pulpotomy, radicular pulpotomy, and root canal treatment.Root canal treatment will be performed using standardized endodontic protocols.Total pulpotomy will be carried out to the level of the canal orifices, followed by hemostasis achieved with 2.5% sodium hypochlorite (NaOCl). A 3-mm-thick layer of mineral trioxide aggregate (MTA) will be placed as the pulpotomy material.Radicular pulpotomy will be performed by removing the pulp tissue a few millimeters apical to the canal orifices. Hemostasis will be achieved using 2.5% NaOCl, and a 3-mm-thick layer of MTA will be placed as the pulpotomy agent.All treated teeth will be restored with glass ionomer cement, followed by a composite resin restoration.Postoperative pain intensity will be assessed using a visual analog scale (VAS) at the following time points: preoperatively, and at 12 hours, 24 hours, 48 hours, and 7 days postoperatively. Clinical and radiographic evaluations will be performed at 3, 6, and 12 months to assess treatment success and periapical health.
Read the detailed description
Clinical Intervention: Local anesthesia will be achieved using an inferior alveolar nerve block with 4% articaine containing 1:100,000 epinephrine. Following rubber dam isolation, all carious tissue will be removed non-selectively using a sterile high-speed diamond bur under water cooling. Caries removal will be completed with a sterile round bur in a low-speed handpiece. Subsequently, treatment will be carried out according to the protocol assigned to the patient's group: total pulpotomy, radicular pulpotomy, or root canal treatment.Group I Total Pulpotomy: After access cavity preparation, pulp vitality will be visually confirmed. The coronal pulp tissue will be completely removed using a sterile high-speed diamond bur with copious water irrigation. The exposed pulp surface will be irrigated with 5 mL of 2.5% sodium hypochlorite (NaOCl). Hemostasis will be attempted by placing a cotton pellet moistened with 2.5% NaOCl onto the pulp chamber floor. If necessary, this procedure will be repeated for up to 10 minutes. The time required to achieve hemostasis will be recorded.
Group II Radicular Pulpotomy: Inflamed coronal pulp tissue will be removed using a large sterile round bur mounted on a high-speed handpiece with air-water spray, extending to the level of the canal orifices. The canal orifices will be identified, and the depth of the pulp chamber will be measured using a Williams periodontal probe. A sterile long-shank round carbide bur will be marked with an endodontic file stopper corresponding to the pulp chamber depth plus 3 mm. Radicular pulp tissue will then be removed to a depth of approximately 2-3 mm apical to the canal orifices.Small cotton pellets moistened with 2.5% NaOCl will be individually placed into each canal orifice at the level of pulp excision to achieve hemostasis. If necessary, this step will be repeated for up to 10 minutes. The time required to achieve hemostasis will be recorded.MTA Application (Groups I and II): After achieving hemostasis, the pulp chamber will be irrigated with 5 mL of 2.5% NaOCl. Mineral trioxide aggregate (MTA) will be mixed according to the manufacturer's instructions and placed as a 2-3 mm thick layer over the pulp chamber floor. The material will be gently condensed using a moist cotton pellet, after which a moist cotton pellet will be placed over the MTA for 10 minutes.Group III Root Canal Treatment: Following access cavity preparation, pulp vitality will be visually confirmed. The canal orifices will be located, and the working length (WL) will be determined using a size 10 K-file and an electronic apex locator, then verified radiographically. Chemomechanical preparation will be performed to the working length using Reciproc files. During instrumentation, root canals will be irrigated with 2.5% NaOCl after every three pecking motions. The final irrigation protocol will consist of: 5 mL of 17% EDTA for 1 minute,5 mL of distilled water, 5 mL of 2.5% NaOCl maintained in the canal for 1 minute, 5 mL of distilled water to neutralize NaOCl.After irrigation, the canals will be dried with sterile paper points and obturated in a single visit using a calcium silicate-based sealer.
Final Restoration: A 2-3 mm layer of resin-modified glass ionomer cement (RMGIC) will be placed over the MTA and light-cured for 20 seconds. RMGIC will also be applied in teeth that have undergone root canal treatment. All teeth will then be restored with resin composite. The rubber dam will be removed, occlusal adjustments will be performed, and the restorations will be finished and polished during the same appointment. Postoperative periapical radiographs will be obtained immediately after treatment. Patients will be recalled for follow-up examinations at 3, 6, and 12 months, or earlier if symptoms occur. Postoperative Pain Management: Patients will be prescribed 400 mg ibuprofen tablets to be taken as needed. They will be instructed to record the frequency of analgesic intake in writing. In cases of severe postoperative pain unresponsive to analgesics, patients will be instructed to contact the operator immediately. Evaluation Criteria and Follow-up Examination Pain Assessment: Patients will record their pain intensity preoperatively and at 12 hours, 24 hours, 48 hours, and 7 days postoperatively using an 11-point visual analog scale (VAS), where 0 represents no pain and 10 represents unbearable pain. Pain scores will be documented by the patients on standardized pain record forms. Clinical and Radiographic Follow-up: Clinical and radiographic evaluations will be performed at 3, 6, and 12 months to assess treatment success.Clinical success criteria will include: Absence of spontaneous pain or discomfort beyond the initial postoperative period, no increased sensitivity to thermal stimuli, tooth mobility not exceeding Grade I, healthy surrounding soft tissues, with no swelling or sinus tract, negative response to percussion and palpation tests. Radiographic success criteria will include: No increase in Periapical Index (PAI) scores at follow-up ,absence of intra- or extraradicular pathology, absence of internal or external root resorption.
Additional Evaluations: Restorative integrity will be assessed at each follow-up visit, and the need for re-restoration will be recorded, pulp sensibility will be evaluated using cold testing and an electric pulp test at all follow-up appointments.
- Conditions
- Post-operative Pain, Pulpitis - Irreversible, Success Rate
- Being tested
- Total Pulpotomy, Radicular pulpotomy, Root canal treatment
- Keywords
- irreversibl pulpitis, total pulpotomy, radicular pulpotomy, vital pulp therapy (VPT), root canal treatment (RCT), pain assessment, vas scale, clinical follow - up, radiographic evaluation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total PulpotomyProcedure or surgery
Total pulpotomy procedures explained in arm descriptions.
Radicular pulpotomyProcedure or surgery
Radicular pulpotomy procedures explained in arm descriptions.
Root canal treatmentProcedure or surgery
Root canal treatment procedures explained in arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Total Pulpotomy | Experimental | After the access cavity is prepared, the vitality of the pulp will be visually confirmed.
The coronal pulp tissue will be removed using a high-speed sterile diamond bur with copious water cooling.
A cotton pellet moistened with 2.5% NaOCl will be applied to the pulp chamber. If necessary, this procedure will be repeated for up to 10 minutes. The time required to achieve hemostasis will be recorded. Receives: Procedure: Total Pulpotomy |
| Radicular Pulpotomy | Experimental | Inflamed coronal pulp tissue will be removed using a large sterile round bur on a high-speed handpiece with air-water spray, down to the level of the canal orifices. The canal orifices will be located, and the depth of the pulp chamber will be measured using a Williams probe.
A sterile long-shank round carbide bur will be marked with an endodontic file stopper (pulp chamber depth + 3 mm), and radicular pulp tissue will be removed from the canal orifice level to approximately 2-3 mm apical depth.
Small cotton pellets moistened with 2.5% NaOCl will be individually placed into each canal orifice, down to the level of pulp excision; if necessary, the procedure will be repeated for up to 10 minutes. The time required to achieve hemostasis will be recorded. Receives: Procedure: Radicular pulpotomy |
| Root Canal Treatment Procedure | Active comparator | After the access cavity is prepared, the vitality of the pulp will be visually confirmed.
Once the canal orifices are located, the working length (WL) will be determined using a No. 10 K-file and an apex locator, and then confirmed radiographically.
Chemomechanical preparation will be performed to the working length using Reciproc files.
After every three pecking motions, the root canals will be irrigated with 2.5% NaOCl.
The final irrigation sequence will be as follows:
* 5 mL of 17% EDTA for 1 minute
* 5 mL of distilled water
* 5 mL of 2.5% NaOCl maintained in the canal for 1 minute
* 5 mL of distilled water (to neutralize NaOCl) After irrigation, canals will be dried with sterile paper points and obturated in a single visit using a calcium silicate-based sealer. Receives: Procedure: Root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical healing
Radiographic periapical status will be assessed using the Periapical Index (PAI) according to Ørstavik et al., with scores ranging from 1 (normal periapical structures) to 5 (severe apical periodontitis), based on the degree of periapical radiolucency. The primary outcome will be periapical lesion healing, evaluated by changes in periapical index (PAI) scores on periapical radiographs taken before treatment and at the 12-month follow-up.
Measured: 1 year
Post-operative pain
Pre-operative and post-operative pain scores were determined according to the Heft-Parker Visual Analog Scale (HP VAS), which consisted of a 10 mm long horizontal line where numerical values were divided into visual categories.
Patients were instructed to score their pain with a value on the HP VAS. The presence or absence of pain was classified according to 4 categories: No pain (level 1, 0), Mild pain (level 2, 1-3 mm), Moderate pain (level 3, 4-6mm), Severe pain (level 4, 7-10 mm).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Dec 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Post-operative 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
- Model description
- This study is designed as a prospective, parallel-group, double-blind, randomized controlled clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Sari, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375576
- Sponsor's protocol ID
- 2314
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD due to confidentiality and privacy considerations.
Publications
Zhu L, Liu W, Deng X, Chen Z, Chen J, Qian W. Full pulpotomy versus root canal therapy in mature teeth with irreversible pulpitis: a randomized controlled trial. BMC Oral Health. 2024 Oct 16;24(1):1231. doi: 10.1186/s12903-024-05011-0.
PubMed 39415163Taha NA, Abuzaid AM, Khader YS. A Randomized Controlled Clinical Trial of Pulpotomy versus Root Canal Therapy in Mature Teeth with Irreversible Pulpitis: Outcome, Quality of Life, and Patients' Satisfaction. J Endod. 2023 Jun;49(6):624-631.e2. doi: 10.1016/j.joen.2023.04.001. Epub 2023 Apr 19.
PubMed 37080387Shah A, Pv A, Sharma S, Kumar V, Chawla A, Logani A. The outcome of full and deep pulpotomy in teeth with extremely deep carious lesion and symptomatic irreversible pulpitis: A non-inferiority randomized controlled trial. Int Endod J. 2025 May;58(5):715-726. doi: 10.1111/iej.14205. Epub 2025 Jan 31.
PubMed 39887741Ricucci D, Siqueira JF Jr, Abdelsayed RA, Lio SG, Rocas IN. Bacterial Invasion of Pulp Blood Vessels in Teeth with Symptomatic Irreversible Pulpitis. J Endod. 2021 Dec;47(12):1854-1864. doi: 10.1016/j.joen.2021.09.010. Epub 2021 Sep 29.
PubMed 34597722Moreno JO, Alves FR, Goncalves LS, Martinez AM, Rocas IN, Siqueira JF Jr. Periradicular status and quality of root canal fillings and coronal restorations in an urban Colombian population. J Endod. 2013 May;39(5):600-4. doi: 10.1016/j.joen.2012.12.020. Epub 2013 Feb 15.
PubMed 23611376Levin LG, Law AS, Holland GR, Abbott PV, Roda RS. Identify and define all diagnostic terms for pulpal health and disease states. J Endod. 2009 Dec;35(12):1645-57. doi: 10.1016/j.joen.2009.09.032.
PubMed 19932339Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20.
PubMed 29061359European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.
PubMed 30664240Duncan HF. Present status and future directions-Vital pulp treatment and pulp preservation strategies. Int Endod J. 2022 May;55 Suppl 3(Suppl 3):497-511. doi: 10.1111/iej.13688. Epub 2022 Feb 3.
PubMed 35080024Demant S, Dabelsteen S, Bjorndal L. A macroscopic and histological analysis of radiographically well-defined deep and extremely deep carious lesions: carious lesion characteristics as indicators of the level of bacterial penetration and pulp response. Int Endod J. 2021 Mar;54(3):319-330. doi: 10.1111/iej.13424. Epub 2020 Nov 18.
PubMed 33012046Careddu R, Duncan HF. A prospective clinical study investigating the effectiveness of partial pulpotomy after relating preoperative symptoms to a new and established classification of pulpitis. Int Endod J. 2021 Dec;54(12):2156-2172. doi: 10.1111/iej.13629. Epub 2021 Sep 26.
PubMed 34490637Asgary S, Eghbal MJ, Shahravan A, Saberi E, Baghban AA, Parhizkar A. Outcomes of root canal therapy or full pulpotomy using two endodontic biomaterials in mature permanent teeth: a randomized controlled trial. Clin Oral Investig. 2022 Mar;26(3):3287-3297. doi: 10.1007/s00784-021-04310-y. Epub 2021 Dec 2.
PubMed 34854987Asgary S, Eghbal MJ. The effect of pulpotomy using a calcium-enriched mixture cement versus one-visit root canal therapy on postoperative pain relief in irreversible pulpitis: a randomized clinical trial. Odontology. 2010 Jul;98(2):126-33. doi: 10.1007/s10266-010-0127-2. Epub 2010 Jul 23.
PubMed 20652790
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Outcomes of Total Pulpotomy, Radicular Pulpotomy, and Root Canal Treatment in Teeth With Extremely Deep Caries and Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT07375576
- Acronym / sponsor ID
- 2314
- Conditions
- Post-operative Pain, Pulpitis - Irreversible, Success Rate
- Keywords
- irreversibl pulpitis, total pulpotomy, radicular pulpotomy, vital pulp therapy (VPT), root canal treatment (RCT), pain assessment, vas scale, clinical follow - up
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 29 Jan 2026 (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 study is to evaluate the clinical effectiveness of total pulpotomy (TP), radicular pulpotomy (RP), and root canal treatment (RCT) in mandibular premolar and/or molar teeth diagnosed with symptomatic irreversible pulpitis, with respect to postoperative pain control and treatment success.Materials and Methods:A total of 99 mandibular premolar and molar teeth will be included in this study. The teeth will be randomly allocated into three groups (n = 33 per group): total pulpotomy, radicular pulpotomy, and root canal treatment.Root canal treatment will be performed using standardized endodontic protocols.Total pulpotomy will be carried out to the level of the canal orifices, followed by hemostasis achieved with 2.5% sodium hypochlorite (NaOCl). A 3-mm-thick layer of mineral trioxide aggregate (MTA) will be placed as the pulpotomy material.Radicular pulpotomy will be performed by removing the pulp tissue a few millimeters apical to the canal orifices. Hemostasis will be achieved using 2.5% NaOCl, and a 3-mm-thick layer of MTA will be placed as the pulpotomy agent.All treated teeth will be restored with glass ionomer cement, followed by a composite resin restoration.Postoperative pain intensity will be assessed using a visual analog scale (VAS) at the following time points: preoperatively, and at 12 hours, 24 hours, 48 hours, and 7 days postoperatively. Clinical and radiographic evaluations will be performed at 3, 6, and 12 months to assess treatment success and periapical health.
Detailed description
Clinical Intervention: Local anesthesia will be achieved using an inferior alveolar nerve block with 4% articaine containing 1:100,000 epinephrine. Following rubber dam isolation, all carious tissue will be removed non-selectively using a sterile high-speed diamond bur under water cooling. Caries removal will be completed with a sterile round bur in a low-speed handpiece. Subsequently, treatment will be carried out according to the protocol assigned to the patient's group: total pulpotomy, radicular pulpotomy, or root canal treatment.Group I Total Pulpotomy: After access cavity preparation, pulp vitality will be visually confirmed. The coronal pulp tissue will be completely removed using a sterile high-speed diamond bur with copious water irrigation. The exposed pulp surface will be irrigated with 5 mL of 2.5% sodium hypochlorite (NaOCl). Hemostasis will be attempted by placing a cotton pellet moistened with 2.5% NaOCl onto the pulp chamber floor. If necessary, this procedure will be repeated for up to 10 minutes. The time required to achieve hemostasis will be recorded.
Group II Radicular Pulpotomy: Inflamed coronal pulp tissue will be removed using a large sterile round bur mounted on a high-speed handpiece with air-water spray, extending to the level of the canal orifices. The canal orifices will be identified, and the depth of the pulp chamber will be measured using a Williams periodontal probe. A sterile long-shank round carbide bur will be marked with an endodontic file stopper corresponding to the pulp chamber depth plus 3 mm. Radicular pulp tissue will then be removed to a depth of approximately 2-3 mm apical to the canal orifices.Small cotton pellets moistened with 2.5% NaOCl will be individually placed into each canal orifice at the level of pulp excision to achieve hemostasis. If necessary, this step will be repeated for up to 10 minutes. The time required to achieve hemostasis will be recorded.MTA Application (Groups I and II): After achieving hemostasis, the pulp chamber will be irrigated with 5 mL of 2.5% NaOCl. Mineral trioxide aggregate (MTA) will be mixed according to the manufacturer's instructions and placed as a 2-3 mm thick layer over the pulp chamber floor. The material will be gently condensed using a moist cotton pellet, after which a moist cotton pellet will be placed over the MTA for 10 minutes.Group III Root Canal Treatment: Following access cavity preparation, pulp vitality will be visually confirmed. The canal orifices will be located, and the working length (WL) will be determined using a size 10 K-file and an electronic apex locator, then verified radiographically. Chemomechanical preparation will be performed to the working length using Reciproc files. During instrumentation, root canals will be irrigated with 2.5% NaOCl after every three pecking motions. The final irrigation protocol will consist of: 5 mL of 17% EDTA for 1 minute,5 mL of distilled water, 5 mL of 2.5% NaOCl maintained in the canal for 1 minute, 5 mL of distilled water to neutralize NaOCl.After irrigation, the canals will be dried with sterile paper points and obturated in a single visit using a calcium silicate-based sealer.
Final Restoration: A 2-3 mm layer of resin-modified glass ionomer cement (RMGIC) will be placed over the MTA and light-cured for 20 seconds. RMGIC will also be applied in teeth that have undergone root canal treatment. All teeth will then be restored with resin composite. The rubber dam will be removed, occlusal adjustments will be performed, and the restorations will be finished and polished during the same appointment. Postoperative periapical radiographs will be obtained immediately after treatment. Patients will be recalled for follow-up examinations at 3, 6, and 12 months, or earlier if symptoms occur. Postoperative Pain Management: Patients will be prescribed 400 mg ibuprofen tablets to be taken as needed. They will be instructed to record the frequency of analgesic intake in writing. In cases of severe postoperative pain unresponsive to analgesics, patients will be instructed to contact the operator immediately. Evaluation Criteria and Follow-up Examination Pain Assessment: Patients will record their pain intensity preoperatively and at 12 hours, 24 hours, 48 hours, and 7 days postoperatively using an 11-point visual analog scale (VAS), where 0 represents no pain and 10 represents unbearable pain. Pain scores will be documented by the patients on standardized pain record forms. Clinical and Radiographic Follow-up: Clinical and radiographic evaluations will be performed at 3, 6, and 12 months to assess treatment success.Clinical success criteria will include: Absence of spontaneous pain or discomfort beyond the initial postoperative period, no increased sensitivity to thermal stimuli, tooth mobility not exceeding Grade I, healthy surrounding soft tissues, with no swelling or sinus tract, negative response to percussion and palpation tests. Radiographic success criteria will include: No increase in Periapical Index (PAI) scores at follow-up ,absence of intra- or extraradicular pathology, absence of internal or external root resorption.
Additional Evaluations: Restorative integrity will be assessed at each follow-up visit, and the need for re-restoration will be recorded, pulp sensibility will be evaluated using cold testing and an electric pulp test at all follow-up appointments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This study is designed as a prospective, parallel-group, double-blind, randomized controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Total Pulpotomy | Experimental | Procedure: Total PulpotomyAfter the access cavity is prepared, the vitality of the pulp will be visually confirmed. The coronal pulp tissue will be removed using a high-speed sterile diamond bur with copious water cooling. A cotton pellet moistened with 2.5% NaOCl will be applied to the pulp chamber. If necessary, this procedure will be repeated for up to 10 minutes. The time required to achieve hemostasis will be recorded. |
| Radicular Pulpotomy | Experimental | Procedure: Radicular pulpotomyInflamed coronal pulp tissue will be removed using a large sterile round bur on a high-speed handpiece with air-water spray, down to the level of the canal orifices. The canal orifices will be located, and the depth of the pulp chamber will be measured using a Williams probe. A sterile long-shank round carbide bur will be marked with an endodontic file stopper (pulp chamber depth + 3 mm), and radicular pulp tissue will be removed from the canal orifice level to approximately 2-3 mm apical depth. Small cotton pellets moistened with 2.5% NaOCl will be individually placed into each canal orifice, down to the level of pulp excision; if necessary, the procedure will be repeated for up to 10 minutes. The time required to achieve hemostasis will be recorded. |
| Root Canal Treatment Procedure | Active comparator | Procedure: Root canal treatmentAfter the access cavity is prepared, the vitality of the pulp will be visually confirmed. Once the canal orifices are located, the working length (WL) will be determined using a No. 10 K-file and an apex locator, and then confirmed radiographically. Chemomechanical preparation will be performed to the working length using Reciproc files. After every three pecking motions, the root canals will be irrigated with 2.5% NaOCl. The final irrigation sequence will be as follows: * 5 mL of 17% EDTA for 1 minute * 5 mL of distilled water * 5 mL of 2.5% NaOCl maintained in the canal for 1 minute * 5 mL of distilled water (to neutralize NaOCl) After irrigation, canals will be dried with sterile paper points and obturated in a single visit using a calcium silicate-based sealer. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy patients of both sexes, aged between 15 and 45 years, with no systemic diseases, will be screened for inclusion in the study. Strict eligibility criteria will be applied.
- The patients included in the study must have restorable, extremely deep carious lesions in the mandibular first and second molars, and first and second premolars; healthy periodontal status (periodontal pocket ≤ 3 mm); and a clinical diagnosis of symptomatic irreversible pulpitis (history of spontaneous pain, pain persisting after removal of the stimulus, exaggerated and prolonged response to cold testing, and a positive response to the electric pulp test).
Key exclusion criteria (2 listed)
- Teeth with cracks or cusp fractures, subgingival caries, or periapical radiolucency will not be included in the study.
- Informed consent will be obtained from all included patients.
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 |
|---|---|---|
| Total PulpotomyTotal pulpotomy procedures explained in arm descriptions. | Procedure or surgery | Total Pulpotomy |
| Radicular pulpotomyRadicular pulpotomy procedures explained in arm descriptions. | Procedure or surgery | Radicular Pulpotomy |
| Root canal treatmentRoot canal treatment procedures explained in arm descriptions. | Procedure or surgery | Root Canal Treatment Procedure |
Primary outcome
Periapical healing
Time frame: 1 year
Radiographic periapical status will be assessed using the Periapical Index (PAI) according to Ørstavik et al., with scores ranging from 1 (normal periapical structures) to 5 (severe apical periodontitis), based on the degree of periapical radiolucency. The primary outcome will be periapical lesion healing, evaluated by changes in periapical index (PAI) scores on periapical radiographs taken before treatment and at the 12-month follow-up.
Post-operative pain
Time frame: 1 week
Pre-operative and post-operative pain scores were determined according to the Heft-Parker Visual Analog Scale (HP VAS), which consisted of a 10 mm long horizontal line where numerical values were divided into visual categories. Patients were instructed to score their pain with a value on the HP VAS. The presence or absence of pain was classified according to 4 categories: No pain (level 1, 0), Mild pain (level 2, 1-3 mm), Moderate pain (level 3, 4-6mm), Severe pain (level 4, 7-10 mm).
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 5 Jun 2026.
- Background: PubMed 39415163Zhu L, Liu W, Deng X, Chen Z, Chen J, Qian W. Full pulpotomy versus root canal therapy in mature teeth with irreversible pulpitis: a randomized controlled trial. BMC Oral Health. 2024 Oct 16;24(1):1231. doi: 10.1186/s12903-024-05011-0.
- Background: PubMed 37080387Taha NA, Abuzaid AM, Khader YS. A Randomized Controlled Clinical Trial of Pulpotomy versus Root Canal Therapy in Mature Teeth with Irreversible Pulpitis: Outcome, Quality of Life, and Patients' Satisfaction. J Endod. 2023 Jun;49(6):624-631.e2. doi: 10.1016/j.joen.2023.04.001. Epub 2023 Apr 19.
- Background: PubMed 39887741Shah A, Pv A, Sharma S, Kumar V, Chawla A, Logani A. The outcome of full and deep pulpotomy in teeth with extremely deep carious lesion and symptomatic irreversible pulpitis: A non-inferiority randomized controlled trial. Int Endod J. 2025 May;58(5):715-726. doi: 10.1111/iej.14205. Epub 2025 Jan 31.
- Background: PubMed 34597722Ricucci D, Siqueira JF Jr, Abdelsayed RA, Lio SG, Rocas IN. Bacterial Invasion of Pulp Blood Vessels in Teeth with Symptomatic Irreversible Pulpitis. J Endod. 2021 Dec;47(12):1854-1864. doi: 10.1016/j.joen.2021.09.010. Epub 2021 Sep 29.
- Background: PubMed 23611376Moreno JO, Alves FR, Goncalves LS, Martinez AM, Rocas IN, Siqueira JF Jr. Periradicular status and quality of root canal fillings and coronal restorations in an urban Colombian population. J Endod. 2013 May;39(5):600-4. doi: 10.1016/j.joen.2012.12.020. Epub 2013 Feb 15.
- Background: PubMed 19932339Levin LG, Law AS, Holland GR, Abbott PV, Roda RS. Identify and define all diagnostic terms for pulpal health and disease states. J Endod. 2009 Dec;35(12):1645-57. doi: 10.1016/j.joen.2009.09.032.
- Background: PubMed 29061359Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20.
- Background: PubMed 30664240European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.
- Background: PubMed 35080024Duncan HF. Present status and future directions-Vital pulp treatment and pulp preservation strategies. Int Endod J. 2022 May;55 Suppl 3(Suppl 3):497-511. doi: 10.1111/iej.13688. Epub 2022 Feb 3.
- Background: PubMed 33012046Demant S, Dabelsteen S, Bjorndal L. A macroscopic and histological analysis of radiographically well-defined deep and extremely deep carious lesions: carious lesion characteristics as indicators of the level of bacterial penetration and pulp response. Int Endod J. 2021 Mar;54(3):319-330. doi: 10.1111/iej.13424. Epub 2020 Nov 18.
- Background: PubMed 34490637Careddu R, Duncan HF. A prospective clinical study investigating the effectiveness of partial pulpotomy after relating preoperative symptoms to a new and established classification of pulpitis. Int Endod J. 2021 Dec;54(12):2156-2172. doi: 10.1111/iej.13629. Epub 2021 Sep 26.
- Background: PubMed 34854987Asgary S, Eghbal MJ, Shahravan A, Saberi E, Baghban AA, Parhizkar A. Outcomes of root canal therapy or full pulpotomy using two endodontic biomaterials in mature permanent teeth: a randomized controlled trial. Clin Oral Investig. 2022 Mar;26(3):3287-3297. doi: 10.1007/s00784-021-04310-y. Epub 2021 Dec 2.
- Individual participant dataSharing planned: No. No plan to share IPD due to confidentiality and privacy considerations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Pulpotomy, Radicular pulpotomy and Root canal treatment in people with Post-operative Pain and Pulpitis - Irreversible, 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 2 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 5 Jun 2026. 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?
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 Efkan Aksay (+905062654889, efkanaksay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periapical healing (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT07375576, which also lists 13 linked publications.
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 5 Jun 2026.