Irreversible PulpitisNCT06504108
Full Pulpotomy Procedure of Permanent Molar Teeth of Adults Using Calcium Silicate-based Sealer Material
A study testing Calcium silicate-based sealer full Pulpotomy, Calcium silicate-based premixed putty full Pulpotomy and Full Pulpotomy in people with Irreversible Pulpitis, run by Al-Azhar University at 2 sites in Egypt.
Trial summary
This clinical study aims to assess the efficacy of using calcium silicate based sealer as a capping material after complete removal of coronal pulp tissue. The study will evaluate both the clinical and radiographic changes. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Calcium silicate-based sealer full Pulpotomy, Calcium silicate-based premixed putty full Pulpotomy and Full Pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesEgypt
- Study dates
- Jul 2024to May 2026
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Vital mandibular molar teeth with mature apices.
- Teeth that respond positively to cold testing.
- Teeth without any signs of necrosis including sinus tract or swelling.
- Teeth with caries extending ≥ 2/3 of dentine or exposing the pulp.
- Teeth with symptomatic irreversible pulpitis with/without apical periodontitis.
- Teeth without periodontal diseases or mobility.
Show all 9Show fewer
- Teeth without root resorption, detectable pulp chamber and root canal calcification or history of trauma.
- Patients from both genders with age range from 20 to 45 years old.
- Patients with good or moderate oral hygiene and without any systemic diseases.
Who cannot join
- Pre-operative criteria:
- Non-vital teeth.
- Teeth with irreversible pulpitis with apical periodontitis.
- Teeth with immature apices.
- Teeth with Periodontal disease or mobility grade II or III.
- Teeth that are badly decayed and need post and core placement.
Show all 22Show fewer
- Patients refused to continue treatment procedures or refuse to commit to periodic follow-up sessions.
- Non-restorable teeth.
- Intra-operative criteria:
- If hemostasis could not be achieved within 6 minutes after full pulpotomy.
- Teeth with partial necrosis.
- No bleeding after access cavity preparation.
- Post-operative criteria:
- presence of Swelling.
- presence of Sinus tract.
- Pain on percussion after the end of the first week.
- Pain with palpation.
- Pain on biting after the end of first week.
- Mobility of the tooth.
- Fracture of tooth structure that renders the tooth non-restorable.
- Fracture of the restoration during the evaluation.
- Probing depth more than 3 mm.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Dental Medicine, Al-Azhar University
Cairo, 11651
Moataz A Alkhawas, PhD, moataz-bellahalkhawas.209@azhar.edu.eg
Mahmoud Y Abdelsalam, Master Degree
Faculty of Dental Medicine, Al-Azhar University
Cairo, 11651
Moataz A Alkhawas, Professor, 8003333333, moataz-bellahalkhawas.209@azhar.edu.eg
Motaz M Elsadat, Lecturer, 8002222222, motazelsadat@gmail.com
About this study
Official title: Evaluation Of The Efficacy Of Using Calcium-Silicate Based Sealers As A Pulp Capping Material After Adult Pulpotomy: An In-vivo Study
This clinical study aims to assess the efficacy of using calcium silicate based sealer as a capping material after complete removal of coronal pulp tissue. The study will evaluate both the clinical and radiographic changes.
Read the detailed description
Root canal treatment has always been considered the first line of treatment for carious teeth with symptomatic irreversible pulpitis for a long time. However, after the evolution of calcium silicate based materials a more conservative option, which is pulpotomy began to gain reliability, especially that it preserves the vitality of the radicular pulp, clinically simpler, less time-consuming, and more cost-effective compared to conventional root canal treatment.
In this study the investigators assess the clinical and radiographic success rate of using calcium silicate based sealer as a pulp capping material in permanent molars after pulpotomy.
For the best of the investigators\' knowledge, there is no available clinical data on the use of calcium-silicate based sealers as a pulp capping material in pulpotomy of permanent molars with symptoms of irreversible pulpitis.
- Conditions
- Irreversible Pulpitis
- Being tested
- Calcium silicate-based sealer full Pulpotomy, Calcium silicate-based premixed putty full Pulpotomy, Full Pulpotomy
- Keywords
- pulpotomy, calcium silicate-based sealer, irreversible pulpitis, MTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium silicate-based sealer full PulpotomyProcedure or surgery
Using calcium silicate-based sealer as a capping agent after full pulpotomy
Calcium silicate-based premixed putty full PulpotomyProcedure or surgery
Using calcium silicate-based premixed putty as a capping agent after full pulpotomy
Full PulpotomyProcedure or surgery
Using combination between calcium silicate-based sealer and calcium silicate-based premixed putty as a capping agent after full pulpotomy
| Study group | Role | What they receive |
|---|---|---|
| calcium silicate-based sealer | Experimental | Performing full pulpotomy of permanent mandibular and maxillary molar teeth using calcium silicate-based sealer as a capping agent. Receives: Procedure: Calcium silicate-based sealer full Pulpotomy |
| Premixed calcium silicate-based putty | Active comparator | Performing full pulpotomy of permanent mandibular and maxillary molar teeth using premixed calcium silicate-based putty as a capping agent. Receives: Procedure: Calcium silicate-based premixed putty full Pulpotomy |
| combination between calcium silicate-based sealer and premixed calcium silicate-based putty | Experimental | Performing full pulpotomy of permanent mandibular and maxillary molar teeth using a combination of calcium silicate-based sealer and premixed calcium silicate-based putty as a capping agent. Receives: Procedure: Full Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success after full pulpotomy procedure
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
Measured: immediate postoperative
Radiographic success after full pulpotomy procedure
Radiographic evaluation of the targeted tooth is performed and the treatment is considered successful in case of presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of peri-radicular radiolucency and no loss or break of lamina dura.
Measured: immediate postoperative
Clinical success after full pulpotomy procedure
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling, absence of sinus tract or fistula and absence of tooth mobility.
Measured: At 1 month
Cinical success after full pulpotomy procedure
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
Measured: At 3 months
Clinical success after full pulpotomy procedure
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
Measured: At 6 months
Radiographic success after full pulpotomy procedure
Radiographic evaluation of the targeted tooth is performed and the treatment is considered successful in case of presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of peri-radicular radiolucency and no loss or break of lamina dura.
Measured: At 6 months
Clinical success after full pulpotomy procedure
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
Measured: At 9 months
Clinical success after full pulpotomy procedure
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
Measured: At 12 months
Radiographic success after full pulpotomy procedure
Radiographic evaluation of the targeted tooth is performed and the treatment is considered successful in case of presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of peri-radicular radiolucency and no loss or break of lamina dura.
Measured: At 12 months
Secondary outcomes (1)
Assessment of Post-operative pain after full pulpotomy procedure
The postoperative pain was assessed by using the modified verbal descriptor Scale (mVDS). Patients were instructed to place a mark on the horizontal scale to represent the intensity of pain experienced, furthermore, they were asked to use the verbal descriptors as a guide. The level of pain was documented at the range of 0-10 numerically and verbally as no pain (0), slight pain (1, 2), moderate pain (3-5), strong pain (6, 7), severe pain (8), and maximum pain (9, 10).
Measured: 6 hours, 24 hours, 48 hours, 72 hours and 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 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Yahia Ramadan Abdelsalam, Al-Azhar University
- Investigators
- Moataz A Elkhawas, PhD, Study chair, Faculty of Dental Medicine, Al-Azhar University, Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504108
- Sponsor's protocol ID
- 959/1498
- Status last verified
- Jul 2024
- First submitted
- 18 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I am planning to share the study protocol and clinical study report
Publications
Taha NA, Al-Khatib H. 4-Year Follow-up of Full Pulpotomy in Symptomatic Mature Permanent Teeth with Carious Pulp Exposure Using a Stainproof Calcium Silicate-based Material. J Endod. 2022 Jan;48(1):87-95. doi: 10.1016/j.joen.2021.09.008. Epub 2021 Sep 24.
PubMed 34563506Asgary 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, Fazlyab M, Baghban AA, Ghoddusi J. Five-year results of vital pulp therapy in permanent molars with irreversible pulpitis: a non-inferiority multicenter randomized clinical trial. Clin Oral Investig. 2015 Mar;19(2):335-41. doi: 10.1007/s00784-014-1244-z. Epub 2014 Apr 27.
PubMed 24771228Eghbal MJ, Asgary S, Baglue RA, Parirokh M, Ghoddusi J. MTA pulpotomy of human permanent molars with irreversible pulpitis. Aust Endod J. 2009 Apr;35(1):4-8. doi: 10.1111/j.1747-4477.2009.00166.x.
PubMed 19335509Lin LM, Ricucci D, Saoud TM, Sigurdsson A, Kahler B. Vital pulp therapy of mature permanent teeth with irreversible pulpitis from the perspective of pulp biology. Aust Endod J. 2020 Apr;46(1):154-166. doi: 10.1111/aej.12392. Epub 2019 Dec 21.
PubMed 31865629Tzanetakis GN, Koletsi D, Georgopoulou M. Treatment outcome of partial pulpotomy using two different calcium silicate materials in mature permanent teeth with symptoms of irreversible pulpitis: A randomized clinical trial. Int Endod J. 2023 Oct;56(10):1178-1196. doi: 10.1111/iej.13955. Epub 2023 Jul 26.
PubMed 37452640Taha 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 37080387
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Efficacy Of Using Calcium-Silicate Based Sealers As A Pulp Capping Material After Adult Pulpotomy: An In-vivo Study
- ClinicalTrials.gov ID
- NCT06504108
- Acronym / sponsor ID
- 959/1498
- Conditions
- Irreversible Pulpitis
- Keywords
- pulpotomy, calcium silicate-based sealer, irreversible pulpitis, MTA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 16 Jul 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.
This clinical study aims to assess the efficacy of using calcium silicate based sealer as a capping material after complete removal of coronal pulp tissue. The study will evaluate both the clinical and radiographic changes.
Detailed description
Root canal treatment has always been considered the first line of treatment for carious teeth with symptomatic irreversible pulpitis for a long time. However, after the evolution of calcium silicate based materials a more conservative option, which is pulpotomy began to gain reliability, especially that it preserves the vitality of the radicular pulp, clinically simpler, less time-consuming, and more cost-effective compared to conventional root canal treatment.
In this study the investigators assess the clinical and radiographic success rate of using calcium silicate based sealer as a pulp capping material in permanent molars after pulpotomy.
For the best of the investigators\' knowledge, there is no available clinical data on the use of calcium-silicate based sealers as a pulp capping material in pulpotomy of permanent molars with symptoms of irreversible pulpitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| calcium silicate-based sealer | Experimental | Procedure: Calcium silicate-based sealer full PulpotomyPerforming full pulpotomy of permanent mandibular and maxillary molar teeth using calcium silicate-based sealer as a capping agent. |
| Premixed calcium silicate-based putty | Active comparator | Procedure: Calcium silicate-based premixed putty full PulpotomyPerforming full pulpotomy of permanent mandibular and maxillary molar teeth using premixed calcium silicate-based putty as a capping agent. |
| combination between calcium silicate-based sealer and premixed calcium silicate-based putty | Experimental | Procedure: Full PulpotomyPerforming full pulpotomy of permanent mandibular and maxillary molar teeth using a combination of calcium silicate-based sealer and premixed calcium silicate-based putty as a capping agent. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Vital mandibular molar teeth with mature apices.
- Teeth that respond positively to cold testing.
- Teeth without any signs of necrosis including sinus tract or swelling.
- Teeth with caries extending ≥ 2/3 of dentine or exposing the pulp.
- Teeth with symptomatic irreversible pulpitis with/without apical periodontitis.
Key exclusion criteria (22 listed)
- Non-vital teeth.
- Teeth with irreversible pulpitis with apical periodontitis.
- Teeth with immature apices.
- Teeth with Periodontal disease or mobility grade II or III.
- Teeth that are badly decayed and need post and core placement.
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 silicate-based sealer full PulpotomyUsing calcium silicate-based sealer as a capping agent after full pulpotomy | Procedure or surgery | calcium silicate-based sealer |
| Calcium silicate-based premixed putty full PulpotomyUsing calcium silicate-based premixed putty as a capping agent after full pulpotomy | Procedure or surgery | Premixed calcium silicate-based putty |
| Full PulpotomyUsing combination between calcium silicate-based sealer and calcium silicate-based premixed putty as a capping agent after full pulpotomy | Procedure or surgery | combination between calcium silicate-based sealer and premixed calcium silicate-based putty |
Primary outcome
Clinical success after full pulpotomy procedure
Time frame: immediate postoperative
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
Radiographic success after full pulpotomy procedure
Time frame: immediate postoperative
Radiographic evaluation of the targeted tooth is performed and the treatment is considered successful in case of presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of peri-radicular radiolucency and no loss or break of lamina dura.
Clinical success after full pulpotomy procedure
Time frame: At 1 month
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling, absence of sinus tract or fistula and absence of tooth mobility.
Cinical success after full pulpotomy procedure
Time frame: At 3 months
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
Clinical success after full pulpotomy procedure
Time frame: At 6 months
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
Radiographic success after full pulpotomy procedure
Time frame: At 6 months
Radiographic evaluation of the targeted tooth is performed and the treatment is considered successful in case of presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of peri-radicular radiolucency and no loss or break of lamina dura.
Clinical success after full pulpotomy procedure
Time frame: At 9 months
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
Clinical success after full pulpotomy procedure
Time frame: At 12 months
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
Radiographic success after full pulpotomy procedure
Time frame: At 12 months
Radiographic evaluation of the targeted tooth is performed and the treatment is considered successful in case of presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of peri-radicular radiolucency and no loss or break of lamina dura.
1 secondary outcome
Assessment of Post-operative pain after full pulpotomy procedure
Time frame: 6 hours, 24 hours, 48 hours, 72 hours and 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 34563506Taha NA, Al-Khatib H. 4-Year Follow-up of Full Pulpotomy in Symptomatic Mature Permanent Teeth with Carious Pulp Exposure Using a Stainproof Calcium Silicate-based Material. J Endod. 2022 Jan;48(1):87-95. doi: 10.1016/j.joen.2021.09.008. Epub 2021 Sep 24.
- 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.
- Background: PubMed 24771228Asgary S, Eghbal MJ, Fazlyab M, Baghban AA, Ghoddusi J. Five-year results of vital pulp therapy in permanent molars with irreversible pulpitis: a non-inferiority multicenter randomized clinical trial. Clin Oral Investig. 2015 Mar;19(2):335-41. doi: 10.1007/s00784-014-1244-z. Epub 2014 Apr 27.
- Background: PubMed 19335509Eghbal MJ, Asgary S, Baglue RA, Parirokh M, Ghoddusi J. MTA pulpotomy of human permanent molars with irreversible pulpitis. Aust Endod J. 2009 Apr;35(1):4-8. doi: 10.1111/j.1747-4477.2009.00166.x.
- Background: PubMed 31865629Lin LM, Ricucci D, Saoud TM, Sigurdsson A, Kahler B. Vital pulp therapy of mature permanent teeth with irreversible pulpitis from the perspective of pulp biology. Aust Endod J. 2020 Apr;46(1):154-166. doi: 10.1111/aej.12392. Epub 2019 Dec 21.
- Background: PubMed 37452640Tzanetakis GN, Koletsi D, Georgopoulou M. Treatment outcome of partial pulpotomy using two different calcium silicate materials in mature permanent teeth with symptoms of irreversible pulpitis: A randomized clinical trial. Int Endod J. 2023 Oct;56(10):1178-1196. doi: 10.1111/iej.13955. Epub 2023 Jul 26.
- 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.
- Individual participant dataSharing planned: Yes. I am planning to share the study protocol and clinical study report
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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.
Moataz A Elkhawas, PhD study chair
Faculty of Dental Medicine, Al-Azhar University, Cairo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium silicate-based sealer full Pulpotomy, Calcium silicate-based premixed putty full Pulpotomy and Full Pulpotomy in people with Irreversible Pulpitis, run by Al-Azhar University at 2 sites in Egypt.
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 9 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Y Abdelsalam, Master Degree (8001111111, mahmoudyahia96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success after full pulpotomy procedure (time frame: immediate postoperative). The study lists 9 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 NCT06504108, which also lists 7 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 16 Jul 2024.