Pulpitis - IrreversibleRCTNCT04719247
Clinical and Radiographic Evaluation of Turmeric, Thymus Vulgaris, Nigella Sativa and Aloe Vera as Pulpotomy Medicaments in Primary Teeth
A study testing Pulpotomy in people with Pulpitis - Irreversible, run by Ain Shams University at 1 site in Egypt.
Trial summary
when caries reaches the pulp of the tooth, it has to be removed and replaced with a material. In this study im examining the clinical and radiographic signs and symptoms after using different natural materials in pulpotomized molars and compared to the formocresol. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 1 Nov 2021
- 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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged from 4 to 7 years old
- Patients who are medically free
- Patients who have a restorable vital deep carious primary molar which is indicated for pulpotomy.
- No clinical signs or symptoms as pain on percussion, tooth mobility, presence of sinus or fistula, history of swelling.
- No radiographic signs of any periapical pathosis or signs of internal or external root resorption.
Who cannot join
- Patients who have any medical condition.
- Teeth that are badly broken down, that cannot be restored.
- Presence of uncontrolled bleeding.
- Clinical evidence of non-vitality such as presence of an abscess or a sinus or premature mobility.
- Radiographic evidence of bone resorption, internal or external root resorption and periapical or interradicular radiolucency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Turmeric, Thymus Vulgaris, Nigella Sativa and Aloe Vera as Pulpotomy Medicaments in Primary Teeth" A Randomized Controlled Study
when caries reaches the pulp of the tooth, it has to be removed and replaced with a material. In this study im examining the clinical and radiographic signs and symptoms after using different natural materials in pulpotomized molars and compared to the formocresol.
Read the detailed description
Patients who have irreversible pulpitis and need pulpotomy will be selected randomly from the out patient clinic. they will be assigned randomly to different study and control groups. pulpotomy will be performed in the second primary molar and 1 of the five materials will be put in the pulp chamber (aloe vera, nigella sativa, thymus vulgaris, turmeric and formocresol). It will be covered with a restoration and a stainless steel crown. Patients follow up will be done after 1,3,6 and 12 months to assess clinical and radiographic signs and symptoms.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
Irreversibly damaged dental pulp is partially removed and a dressing either Turmeric or Thymus Vulgaris or Nigella Sativa or Aloe Vera is placed. Clinical and Radiographic signs and symptoms are assessed and compared with Formocresol.
| Study group | Role | What they receive |
|---|---|---|
| Turmeric | Experimental | Turmeric extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol Receives: Procedure: Pulpotomy |
| Thymus Vulgaris | Experimental | Thymus Vulgaris extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol Receives: Procedure: Pulpotomy |
| Nigella Sativa | Experimental | Nigella Sativa extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol Receives: Procedure: Pulpotomy |
| Aloe Vera | Experimental | Aloe Vera extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol Receives: Procedure: Pulpotomy |
| Formocresol | Active comparator | Formocresol will be used as a dental pulp dressing material after pulpotomy to be compared with other materials. Receives: Procedure: Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical signs and symptoms of pulp reaction
Evaluated using Zurn and Seale criteria. (pain, infection, gingival health, tooth mobility) where 1 indicates asymptomatic and 4 indicates severe discomfort
Measured: 1 to 6 months
Radiographic signs of pulp reaction
Evaluated using Zurn and Seale criteria. (radiolucency, bone resorption, internal or external resorption) where 1 indicates no radiographic changes while 4 indicates the presence of pathologic changes
Measured: 1 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Nov 2019
- Primary completion1 May 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana sharaf, Ain Shams University
- Investigators
- Noha S Kabil, PHD, Study director, ProfessorBasma G Awad, PHD, Study director, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719247
- Sponsor's protocol ID
- PED19-3D
- Acronym
- RCT
- Status last verified
- Dec 2021
- First submitted
- 9 Oct 2020
- Last updated
- 15 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saikiran KV, Kamatham R, Sahiti PS, Nuvvula S. Pulpotomy medicaments in primary teeth: A literature reviewof natural alternatives. SRM J Res Dent Sci 2018; 9:181-5.
Kumar Praveen NH, Nayak Rashmi, Bhaskar Vipin K, Mopkar Pujan P Pulpotomy Medicaments: Continued Search for New Alternatives- A Review. 2014; OHDM - Vol. 13 - No. 4
Al-Dlaigan YH. Pulpotomy Medicaments used in Deciduous Dentition: An Update. J Contemp Dent Pract. 2015 Jun 1;16(6):486-503. doi: 10.5005/jp-journals-10024-1711.
PubMed 26323453Salman BN, Vahabi S, Rad MM. Use of herbs and medicinal plants in dentistry: a review. Journal Dental School 2017; 35, No. 2: 58-64
Subramanyam D, Somasundaram S. Clinical and Radiographic Outcome of Herbal Medicine Versus Standard Pulpotomy Medicaments in Primary Molars: A Systematic Review. Journal of Clinical and Diagnostic Research 2017 Oct; 11(10): ZE12-ZE16
Kumar G, Jalaluddin M, Rout P, Mohanty R, Dileep CL. Emerging trends of herbal care in dentistry. J Clin Diagn Res. 2013 Aug;7(8):1827-9. doi: 10.7860/JCDR/2013/6339.3282. Epub 2013 Aug 1.
PubMed 24086929Kuwatada JS, Raja M, Sood P. Turmeric: A Boon to Oral Health. Int J Oral Care Res 2017;5(4):338-341.
Srivastava R, Jyoti B, Pathak S, Wazir S, Shukla A, Sajid MdZ Aloe Vera: The Herbal Magic Wand. J Clin Den Res Edu 2014; 3 (8).
Huth KC, Paschos E, Hajek-Al-Khatar N, Hollweck R, Crispin A, Hickel R, Folwaczny M. Effectiveness of 4 pulpotomy techniques--randomized controlled trial. J Dent Res. 2005 Dec;84(12):1144-8. doi: 10.1177/154405910508401210.
PubMed 16304444
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Turmeric, Thymus Vulgaris, Nigella Sativa and Aloe Vera as Pulpotomy Medicaments in Primary Teeth" A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04719247
- Acronym / sponsor ID
- RCT / PED19-3D
- Conditions
- Pulpitis - Irreversible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 22 Jan 2021 (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.
when caries reaches the pulp of the tooth, it has to be removed and replaced with a material. In this study im examining the clinical and radiographic signs and symptoms after using different natural materials in pulpotomized molars and compared to the formocresol.
Detailed description
Patients who have irreversible pulpitis and need pulpotomy will be selected randomly from the out patient clinic. they will be assigned randomly to different study and control groups. pulpotomy will be performed in the second primary molar and 1 of the five materials will be put in the pulp chamber (aloe vera, nigella sativa, thymus vulgaris, turmeric and formocresol). It will be covered with a restoration and a stainless steel crown. Patients follow up will be done after 1,3,6 and 12 months to assess clinical and radiographic signs and symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Turmeric | Experimental | Procedure: PulpotomyTurmeric extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol |
| Thymus Vulgaris | Experimental | Procedure: PulpotomyThymus Vulgaris extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol |
| Nigella Sativa | Experimental | Procedure: PulpotomyNigella Sativa extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol |
| Aloe Vera | Experimental | Procedure: PulpotomyAloe Vera extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol |
| Formocresol | Active comparator | Procedure: PulpotomyFormocresol will be used as a dental pulp dressing material after pulpotomy to be compared with other materials. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients aged from 4 to 7 years old
- Patients who are medically free
- Patients who have a restorable vital deep carious primary molar which is indicated for pulpotomy.
- No clinical signs or symptoms as pain on percussion, tooth mobility, presence of sinus or fistula, history of swelling.
- No radiographic signs of any periapical pathosis or signs of internal or external root resorption.
Key exclusion criteria (5 listed)
- Patients who have any medical condition.
- Teeth that are badly broken down, that cannot be restored.
- Presence of uncontrolled bleeding.
- Clinical evidence of non-vitality such as presence of an abscess or a sinus or premature mobility.
- Radiographic evidence of bone resorption, internal or external root resorption and periapical or interradicular radiolucency.
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 |
|---|---|---|
| PulpotomyIrreversibly damaged dental pulp is partially removed and a dressing either Turmeric or Thymus Vulgaris or Nigella Sativa or Aloe Vera is placed. Clinical and Radiographic signs and symptoms are assessed and compared with Formocresol. | Procedure or surgery | Aloe Vera, Formocresol, Nigella Sativa, Thymus Vulgaris, Turmeric |
Primary outcome
Clinical signs and symptoms of pulp reaction
Time frame: 1 to 6 months
Evaluated using Zurn and Seale criteria. (pain, infection, gingival health, tooth mobility) where 1 indicates asymptomatic and 4 indicates severe discomfort
Radiographic signs of pulp reaction
Time frame: 1 to 6 months
Evaluated using Zurn and Seale criteria. (radiolucency, bone resorption, internal or external resorption) where 1 indicates no radiographic changes while 4 indicates the presence of pathologic changes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- BackgroundSaikiran KV, Kamatham R, Sahiti PS, Nuvvula S. Pulpotomy medicaments in primary teeth: A literature reviewof natural alternatives. SRM J Res Dent Sci 2018; 9:181-5.
- BackgroundKumar Praveen NH, Nayak Rashmi, Bhaskar Vipin K, Mopkar Pujan P Pulpotomy Medicaments: Continued Search for New Alternatives- A Review. 2014; OHDM - Vol. 13 - No. 4
- Background: PubMed 26323453Al-Dlaigan YH. Pulpotomy Medicaments used in Deciduous Dentition: An Update. J Contemp Dent Pract. 2015 Jun 1;16(6):486-503. doi: 10.5005/jp-journals-10024-1711.
- BackgroundSalman BN, Vahabi S, Rad MM. Use of herbs and medicinal plants in dentistry: a review. Journal Dental School 2017; 35, No. 2: 58-64
- BackgroundSubramanyam D, Somasundaram S. Clinical and Radiographic Outcome of Herbal Medicine Versus Standard Pulpotomy Medicaments in Primary Molars: A Systematic Review. Journal of Clinical and Diagnostic Research 2017 Oct; 11(10): ZE12-ZE16
- Background: PubMed 24086929Kumar G, Jalaluddin M, Rout P, Mohanty R, Dileep CL. Emerging trends of herbal care in dentistry. J Clin Diagn Res. 2013 Aug;7(8):1827-9. doi: 10.7860/JCDR/2013/6339.3282. Epub 2013 Aug 1.
- BackgroundKuwatada JS, Raja M, Sood P. Turmeric: A Boon to Oral Health. Int J Oral Care Res 2017;5(4):338-341.
- BackgroundSrivastava R, Jyoti B, Pathak S, Wazir S, Shukla A, Sajid MdZ Aloe Vera: The Herbal Magic Wand. J Clin Den Res Edu 2014; 3 (8).
- Background: PubMed 16304444Huth KC, Paschos E, Hajek-Al-Khatar N, Hollweck R, Crispin A, Hickel R, Folwaczny M. Effectiveness of 4 pulpotomy techniques--randomized controlled trial. J Dent Res. 2005 Dec;84(12):1144-8. doi: 10.1177/154405910508401210.
- Individual participant dataSharing planned: No
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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.
Noha S Kabil, PHD study director
Professor
Basma G Awad, PHD study director
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulpotomy in people with Pulpitis - Irreversible, run by Ain Shams University at 1 site 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 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2021. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical signs and symptoms of pulp reaction (time frame: 1 to 6 months). 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 NCT04719247, which also lists 9 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 15 Dec 2021.