CariesNCT05279781
Outcome of Pulpotomy Versus Root Canal Therapy
A study testing Non surgical root canal treatment and Pulpotomy in people with Caries and Pulpitis - Irreversible, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
Root canal therapy (RCT) is indicated once the pulp is diagnosed with irreversible pulpitis. Despite favorable success rate reported for RCT in vital cases, it is time consuming, and might increases fracture susceptibility of teeth. Read more about this study
- Who is it for?
- Ages 9 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Pulpitis - Irreversible
- What is being tested?
- Non surgical root canal treatment and Pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJordan
- Study dates
- 1 Apr 2019to Jan 2025
- 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 9 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medically fit patient
- mature permanent tooth with deep caries
- diagnosis of irreversible pulpits.
- tooth is restored with a direct restoration
Who cannot join
- immature teeth
- teeth were hemostasis cannot be achieved after pulpotomy
- necrotic teeth
- lack of response to cold test
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Jordan University of science and technology
Irbid, 21110
Nessrin Taha, PhD, (62776566110, n.taha@just.edu.jo
+962776566110, nessrin_taha@yahoo.com
About this study
Official title: Quality of Life, Satisfaction and Outcome After Full Pulpotomy Compared to Root Canal Therapy
Root canal therapy (RCT) is indicated once the pulp is diagnosed with irreversible pulpitis. Despite favorable success rate reported for RCT in vital cases, it is time consuming, and might increases fracture susceptibility of teeth. With the advancement of materials and better understanding of pulpal healing, vital pulp therapy is practiced as an alternative treatment with high success rate. The aim of this study is to explore the outcome, quality of life and patient satisfaction after full pulpotomy compared to RCT.
Read the detailed description
Permanent molar teeth with carious pulp exposure and mature roots as evident on the preoperative periapical radiograph will be included in the study. The teeth will be randomly divided into 2 groups (n=30). The first group will be treated with Biodentine full pulpotomy and the second group will be endodontically treated. Based on a previously validated questionnaire. The quality of life and satisfaction of patients after pulpotomy treatment will be evaluated compared to those after endodontic treatment. Clinical and radiographic assessment of the treated teeth will be done 3, 6 and 12 months postoperatively. Pain level will be recorded preoperatively and 1, 2, 3, 5 and 7 days after treatment.
The questionnaire consists of five components:
- Characteristics of the patient; including age, gender, socioeconomic status, smoking, oral hygiene practices, frequency of dental visits, and dental history.
- Postoperative complications including postoperative pain, discomfort,or swelling. These symptoms will be evaluated after 1, 2, 3,5 and 7 days by contacting the patient on the phone and at follow up visits at 3, 6, and 12 months.
- Quality of life instruments designed
- Semantic scales designed to evaluate patient satisfaction with the treatment received.
Clinical and radiographic assessment of the treated teeth will be recorded. Success will be defined as clinically asymptomatic tooth with no sinus tract or swelling or periapical lesion.
Data will be analysed statistically using appropriate tests based on the distribution of the results.
- Conditions
- Caries, Pulpitis - Irreversible
- Being tested
- Non surgical root canal treatment, Pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non surgical root canal treatmentProcedure or surgery
Complete root canal treatment will be performed followed by direct restoration
PulpotomyProcedure or surgery
Full pulpotomy followed by direct restoration
| Study group | Role | What they receive |
|---|---|---|
| Root canal treatment group | Active comparator | This group will receive complete root canal therapy Receives: Procedure: Non surgical root canal treatment |
| Pulpotomy group | Active comparator | This group will receive full pulpotomy Receives: Procedure: Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain level on numerical pain scale
Pain level after treatment will be assessed on a numerical scale from 0-10 where is zero refer to no pain and 10 is the most sever pain.
Measured: 7 days
Post operative pain level on visual analogue scale
Pain level after treatment will be assessed on a visual analogy scale from 0-10, where is zero refer to no pain and 10 is the most sever pain.
Measured: 7 days
Secondary outcomes (2)
Clinical success
The tooth should be pain free, no sinus tract, no tenderness to palpation and no swelling. As measured by clinical examination
Measured: 6, 12, 24, 48 months
Radiographic success
Periapical x-ray will be taken it should show no bone lesions or root resorption
Measured: 6, 12, 24, 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Apr 2019
- Primary completion20 Sep 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CariesStudies 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
- Two groups. One will receive root canal treatment t and the other will receive pulpotomy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nessrin Taha, PhD, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279781
- Sponsor's protocol ID
- 375/2019
- Status last verified
- Oct 2022
- First submitted
- 23 Nov 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After collection of data and publication , data might be made available for the benefit off other researchers
Publications
Taha NA, About I, Sedgley CM, Messer HH. Conservative Management of Mature Permanent Teeth with Carious Pulp Exposure. J Endod. 2020 Sep;46(9S):S33-S41. doi: 10.1016/j.joen.2020.06.025.
PubMed 32950193
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life, Satisfaction and Outcome After Full Pulpotomy Compared to Root Canal Therapy
- ClinicalTrials.gov ID
- NCT05279781
- Acronym / sponsor ID
- 375/2019
- Conditions
- Caries, Pulpitis - Irreversible
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 15 Mar 2022 (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.
Root canal therapy (RCT) is indicated once the pulp is diagnosed with irreversible pulpitis. Despite favorable success rate reported for RCT in vital cases, it is time consuming, and might increases fracture susceptibility of teeth. With the advancement of materials and better understanding of pulpal healing, vital pulp therapy is practiced as an alternative treatment with high success rate. The aim of this study is to explore the outcome, quality of life and patient satisfaction after full pulpotomy compared to RCT.
Detailed description
Permanent molar teeth with carious pulp exposure and mature roots as evident on the preoperative periapical radiograph will be included in the study. The teeth will be randomly divided into 2 groups (n=30). The first group will be treated with Biodentine full pulpotomy and the second group will be endodontically treated. Based on a previously validated questionnaire. The quality of life and satisfaction of patients after pulpotomy treatment will be evaluated compared to those after endodontic treatment. Clinical and radiographic assessment of the treated teeth will be done 3, 6 and 12 months postoperatively. Pain level will be recorded preoperatively and 1, 2, 3, 5 and 7 days after treatment.
The questionnaire consists of five components:
- Characteristics of the patient; including age, gender, socioeconomic status, smoking, oral hygiene practices, frequency of dental visits, and dental history.
- Postoperative complications including postoperative pain, discomfort,or swelling. These symptoms will be evaluated after 1, 2, 3,5 and 7 days by contacting the patient on the phone and at follow up visits at 3, 6, and 12 months.
- Quality of life instruments designed
- Semantic scales designed to evaluate patient satisfaction with the treatment received.
Clinical and radiographic assessment of the treated teeth will be recorded. Success will be defined as clinically asymptomatic tooth with no sinus tract or swelling or periapical lesion.
Data will be analysed statistically using appropriate tests based on the distribution of the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups. One will receive root canal treatment t and the other will receive pulpotomy.
| Arm | Type | Receives |
|---|---|---|
| Root canal treatment group | Active comparator | Procedure: Non surgical root canal treatmentThis group will receive complete root canal therapy |
| Pulpotomy group | Active comparator | Procedure: PulpotomyThis group will receive full pulpotomy |
Who may qualify
- Ages
- 9 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Medically fit patient
- mature permanent tooth with deep caries
- diagnosis of irreversible pulpits.
- tooth is restored with a direct restoration
Key exclusion criteria (4 listed)
- immature teeth
- teeth were hemostasis cannot be achieved after pulpotomy
- necrotic teeth
- lack of response to cold test
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 |
|---|---|---|
| Non surgical root canal treatmentComplete root canal treatment will be performed followed by direct restoration | Procedure or surgery | Root canal treatment group |
| PulpotomyFull pulpotomy followed by direct restoration | Procedure or surgery | Pulpotomy group |
Primary outcome
Post operative pain level on numerical pain scale
Time frame: 7 days
Pain level after treatment will be assessed on a numerical scale from 0-10 where is zero refer to no pain and 10 is the most sever pain.
Post operative pain level on visual analogue scale
Time frame: 7 days
Pain level after treatment will be assessed on a visual analogy scale from 0-10, where is zero refer to no pain and 10 is the most sever pain.
2 secondary outcomes
Clinical success
Time frame: 6, 12, 24, 48 months
Radiographic success
Time frame: 6, 12, 24, 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Results publication: PubMed 32950193Taha NA, About I, Sedgley CM, Messer HH. Conservative Management of Mature Permanent Teeth with Carious Pulp Exposure. J Endod. 2020 Sep;46(9S):S33-S41. doi: 10.1016/j.joen.2020.06.025.
- Individual participant dataSharing planned: No. After collection of data and publication , data might be made available for the benefit off other researchers
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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.
Nessrin Taha, PhD principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non surgical root canal treatment and Pulpotomy in people with Caries and Pulpitis - Irreversible, run by Jordan University of Science and Technology at 1 site in Jordan.
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 4 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 26 Oct 2022. 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 Jordan. 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 Prof Taha (+962776566110, n.taha@just.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain level on numerical pain scale (time frame: 7 days). 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 NCT05279781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.