Irreversible PulpitisNCT07610057
R. Officinalis as Pulpotomy Agent in Permanent Teeth With Irreversible Pulpitis
A study testing MTA Pulpotomy and Rosemarinus officinalis extract pulpotomy in people with Irreversible Pulpitis and Pulpotomy, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
This study evaluates and compares the clinical and radiographic outcomes of Rosmarinus officinalis and Mineral Trioxide Aggregate (MTA) when used as pulpotomy medicaments in vital mature permanent teeth with irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Irreversible Pulpitis, Pulpotomy, MTA Vital Tooth Pulpotomy
- What is being tested?
- MTA Pulpotomy and Rosemarinus officinalis extract pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2026to 31 Dec 2026
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy patients (ASA classification 1 and 2) of age range of 18-40 of both sexes would be included.
- Vital mature permanent posterior teeth with deep caries approaching the pulp as seen on periapical x-ray.
- Pain indicative of irreversible pulpitis (spontaneous pain or pain exacerbated by a cold stimulus which could last from a few seconds to hours), which a cold test could reproduce.
- Tooth will be selected on the basis of working diagnosis i.e. successful hemostasis within 5 minutes after removal of coronal pulp.
- Absence of clinical signs or symptoms suggesting a non-vital tooth such as tenderness to percussion or palpation, mobility, presence of abscess, soft tissue swelling or suppurating sinus.
- Absence of radiographic changes as; furcation or periapical pathology, internal or external root resorption or calcification in the canals.
- The tooth structure of selected teeth should be restorable after completion of the treatment
Who cannot join
- Patients with ASA classification 3, 4 ,5 and 6 would be
- Patients taking antibiotics within last 2 weeks.
- Teeth with pulp necrosis, cracked tooth, internal or external resorption, calcified canals, acute or chronic apical periodontitis with an associated sinus tract or periapical radiolucency.
- Periodontally compromised tooth.
- Uncooperative patients or failure to obtain authorization from patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Punjab Dental Hospital, Lahore .
Lahore, Punjab Province, 54000
About this study
Official title: Comparative Clinical and Radiographic Evaluation of Rosmarinus Officinalis Versus Mineral Trioxide Aggregate as Pulpotomy Medicament in Vital Mature Permanent Teeth With Irreversible Pulpitis
This study evaluates and compares the clinical and radiographic outcomes of Rosmarinus officinalis and Mineral Trioxide Aggregate (MTA) when used as pulpotomy medicaments in vital mature permanent teeth with irreversible pulpitis. The aim is to determine the effectiveness of both materials in terms of pain reduction and periapical healing. While MTA is considered a gold standard, it has limitations such as high cost, long setting time, and potential discoloration. Therefore, this study investigates Rosmarinus officinalis as a natural, cost-effective alternative with comparable therapeutic potential. This study also provide an alternative to RCT in teeth with irreversible pulpitis
Read the detailed description
Traditionally, teeth with irreversible pulpitis have been treated either by root canal therapy or extraction, yet root canal treatment, although considered the gold standard, still presents limitations because it is technique-sensitive, invasive, time-consuming, and costly. To address these issues, more affordable and minimally invasive alternatives are being explored. With better understanding of the regenerative and healing abilities of inflamed pulp, along with the development of biologically active materials, vital pulp therapy is now increasingly viewed as a suitable alternative for managing irreversible pulpitis. Mineral trioxide aggregate is widely accepted as the current gold standard, but its drawbacks-including high cost, extended setting time and potential tooth discoloration-remain significant concerns. As a result, newer materials are being evaluated that are more cost-effective while avoiding these disadvantages.
One such material, Rosmarinus officinalis, has been used in vital pulp therapy of primary molars and has shown promising results. Despite the documented antimicrobial and anti-inflammatory properties of R. officinalis, its use as a pulpotomy agent in permanent teeth with irreversible pulpitis has not yet been investigated. This study aims to compare the outcomes of pulpotomy treatment using R. officinalis extract both clinically and radiographically versus MTA. This may help provide an alternative to RCT and a more economical option than MTA, while aiming for comparable effectiveness and addressing the limitations associated with MTA. Healthy young adults exhibiting signs and symptoms of irreversible pulpitis in at least one permanent posterior tooth, showing no periapical radiolucency in a periapical x-ray, along with the absence of swelling or sinus tract formation will be selected. Only the teeth with hemostasis achieved following the removal of coronal pulp will be included.
A randomized control trail will be conducted, wherein participants will be randomly assigned, using lottery method, to two groups, each consisting of 50 individuals of age 18-40 years of both sexes. After administration of anesthesia and isolation using a rubber dam, a sterile diamond round bur in a high-speed handpiece with water spray will used to remove enamel caries and carbide round bur in slow speed handpiece is used to remove dentinal caries. After the access opening, the coronal pulp will be removed up to the level of the canal orifice using a spoon excavator. After rinsing with sterile saline, hemostasis will be achieved by placing damp cotton soaked in saline. For group A, cotton will be dipped in R-officinalis extract, and placed over radicular pulp for 5 minutes and the pulp chamber will be sealed with a thick paste of aqueous R. officinalis extract with zinc oxide powder and for group B, white MTA will be prepared according to the manufacturer's instructions and placed in the pulp chamber compacted with a damp cotton pellet. Both will be restored with glass ionomer followed by direct composite. An immediate post-op periapical x-ray will be exposed. For clinical and radiographical evaluation patients will be recalled for follow-up at 1 week, 3 month and 6 months. Statistical analysis will be performed at the significance level of p= 0.05.
- Conditions
- Irreversible Pulpitis, Pulpotomy, MTA Vital Tooth Pulpotomy
- Being tested
- MTA Pulpotomy, Rosemarinus officinalis extract pulpotomy
- Keywords
- pulpotomy, rosemarinus officinalis, MTA, permanent teeth with irreversible pulpitis, Vital pulp theray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTA PulpotomyProcedure or surgery
MTA shall be mixed according to the manufacturer's instructions (PD SWISS). After achieving a creamy mixture, MTA shall be delivered to the pulp chamber using an amalgam carrier to a 1-2mm thickness. Using a moist pellet, it will be condensed gently over the exposed pulp stumps. Once an initial set of MTA is achieved, the access cavity shall be restored with a glass ionomer cement and composite restoration.
Rosemarinus officinalis extract pulpotomyProcedure or surgery
A sterile cotton pellet dipped and squeezed in 6.25% aqueous extract of R-officinalis will be placed over the radicular pulp for 5 minutes. Then, the pulp chamber will be sealed with a thick paste aqueous extract of R. officinalis and zinc oxide powder. The access cavity shall be restored with glass ionomer cement and a composite restoration.
| Study group | Role | What they receive |
|---|---|---|
| Control Group with MTA pulpotomy | Active comparator | Pulpotomy Medicaent in control group Receives: Procedure: MTA Pulpotomy |
| Intervention | Experimental | R. officinalis as pulpotomy medicament Receives: Procedure: Rosemarinus officinalis extract pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain After Intervention, Tenderness to palpation, percussion , Swelling
The incidence and intensity of pain will be assessed postoperatively using the Visual Analogue scale.
Pain intensity will be noted as no pain (0-4mm), mild pain (5-44), moderate pain (45-74mm) and severe pain (75-100mm) on a scale of 0-100mm
Measured: Preop Post op after 1 week, 1month 3 month 6 month
Periapical status after intervention
The periapical status will be assessed by using the periapical index [PAI] scoring system. Each tooth will be assigned to one of the PAI scores for the 5 categories within the scale. PAI less than or equal to 2 would be successful outcome.
- Normal periapical structures
- Small changes in bone structures
- Changes in bone structure with mineral loss
- Periodontitis with well-defined radiolucent area
- Severe periodontitis with exacerbating features
Measured: Preop Post op 3 month 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe 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
- Model description
- For group A, cotton will be dipped in R-officinalis extract, and placed over radicular pulp for 5 minutes and the pulp chamber will be sealed with a thick paste of aqueous R. officinalis extract with zinc oxide powder and for group B, white MTA will be prepared according to the manufacturer's instructions and placed in the pulp chamber compacted with a damp cotton pellet. Both will be restored with glass ionomer followed by direct composite. An immediate post-op periapical x-ray will be exposed. For clinical and radiographical evaluation patients will be recalled for follow-up at 1 week, 3 month and 6 months.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zoha Nasir, Postgraduate Medical Institute, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610057
- Sponsor's protocol ID
- 60/24
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical and Radiographic Evaluation of Rosmarinus Officinalis Versus Mineral Trioxide Aggregate as Pulpotomy Medicament in Vital Mature Permanent Teeth With Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT07610057
- Acronym / sponsor ID
- 60/24
- Conditions
- Irreversible Pulpitis, Pulpotomy, MTA Vital Tooth Pulpotomy
- Keywords
- pulpotomy, rosemarinus officinalis, MTA, permanent teeth with irreversible pulpitis, Vital pulp theray
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 May 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.
This study evaluates and compares the clinical and radiographic outcomes of Rosmarinus officinalis and Mineral Trioxide Aggregate (MTA) when used as pulpotomy medicaments in vital mature permanent teeth with irreversible pulpitis. The aim is to determine the effectiveness of both materials in terms of pain reduction and periapical healing. While MTA is considered a gold standard, it has limitations such as high cost, long setting time, and potential discoloration. Therefore, this study investigates Rosmarinus officinalis as a natural, cost-effective alternative with comparable therapeutic potential. This study also provide an alternative to RCT in teeth with irreversible pulpitis
Detailed description
Traditionally, teeth with irreversible pulpitis have been treated either by root canal therapy or extraction, yet root canal treatment, although considered the gold standard, still presents limitations because it is technique-sensitive, invasive, time-consuming, and costly. To address these issues, more affordable and minimally invasive alternatives are being explored. With better understanding of the regenerative and healing abilities of inflamed pulp, along with the development of biologically active materials, vital pulp therapy is now increasingly viewed as a suitable alternative for managing irreversible pulpitis. Mineral trioxide aggregate is widely accepted as the current gold standard, but its drawbacks-including high cost, extended setting time and potential tooth discoloration-remain significant concerns. As a result, newer materials are being evaluated that are more cost-effective while avoiding these disadvantages.
One such material, Rosmarinus officinalis, has been used in vital pulp therapy of primary molars and has shown promising results. Despite the documented antimicrobial and anti-inflammatory properties of R. officinalis, its use as a pulpotomy agent in permanent teeth with irreversible pulpitis has not yet been investigated. This study aims to compare the outcomes of pulpotomy treatment using R. officinalis extract both clinically and radiographically versus MTA. This may help provide an alternative to RCT and a more economical option than MTA, while aiming for comparable effectiveness and addressing the limitations associated with MTA. Healthy young adults exhibiting signs and symptoms of irreversible pulpitis in at least one permanent posterior tooth, showing no periapical radiolucency in a periapical x-ray, along with the absence of swelling or sinus tract formation will be selected. Only the teeth with hemostasis achieved following the removal of coronal pulp will be included.
A randomized control trail will be conducted, wherein participants will be randomly assigned, using lottery method, to two groups, each consisting of 50 individuals of age 18-40 years of both sexes. After administration of anesthesia and isolation using a rubber dam, a sterile diamond round bur in a high-speed handpiece with water spray will used to remove enamel caries and carbide round bur in slow speed handpiece is used to remove dentinal caries. After the access opening, the coronal pulp will be removed up to the level of the canal orifice using a spoon excavator. After rinsing with sterile saline, hemostasis will be achieved by placing damp cotton soaked in saline. For group A, cotton will be dipped in R-officinalis extract, and placed over radicular pulp for 5 minutes and the pulp chamber will be sealed with a thick paste of aqueous R. officinalis extract with zinc oxide powder and for group B, white MTA will be prepared according to the manufacturer's instructions and placed in the pulp chamber compacted with a damp cotton pellet. Both will be restored with glass ionomer followed by direct composite. An immediate post-op periapical x-ray will be exposed. For clinical and radiographical evaluation patients will be recalled for follow-up at 1 week, 3 month and 6 months. Statistical analysis will be performed at the significance level of p= 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- For group A, cotton will be dipped in R-officinalis extract, and placed over radicular pulp for 5 minutes and the pulp chamber will be sealed with a thick paste of aqueous R. officinalis extract with zinc oxide powder and for group B, white MTA will be prepared according to the manufacturer's instructions and placed in the pulp chamber compacted with a damp cotton pellet. Both will be restored with glass ionomer followed by direct composite. An immediate post-op periapical x-ray will be exposed. For clinical and radiographical evaluation patients will be recalled for follow-up at 1 week, 3 month and 6 months.
| Arm | Type | Receives |
|---|---|---|
| Control Group with MTA pulpotomy | Active comparator | Procedure: MTA PulpotomyPulpotomy Medicaent in control group |
| Intervention | Experimental | Procedure: Rosemarinus officinalis extract pulpotomyR. officinalis as pulpotomy medicament |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy patients (ASA classification 1 and 2) of age range of 18-40 of both sexes would be included.
- Vital mature permanent posterior teeth with deep caries approaching the pulp as seen on periapical x-ray.
- Pain indicative of irreversible pulpitis (spontaneous pain or pain exacerbated by a cold stimulus which could last from a few seconds to hours), which a cold test could reproduce.
- Tooth will be selected on the basis of working diagnosis i.e. successful hemostasis within 5 minutes after removal of coronal pulp.
- Absence of clinical signs or symptoms suggesting a non-vital tooth such as tenderness to percussion or palpation, mobility, presence of abscess, soft tissue swelling or suppurating sinus.
Key exclusion criteria (5 listed)
- Patients with ASA classification 3, 4 ,5 and 6 would be
- Patients taking antibiotics within last 2 weeks.
- Teeth with pulp necrosis, cracked tooth, internal or external resorption, calcified canals, acute or chronic apical periodontitis with an associated sinus tract or periapical radiolucency.
- Periodontally compromised tooth.
- Uncooperative patients or failure to obtain authorization from 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 |
|---|---|---|
| MTA PulpotomyMTA shall be mixed according to the manufacturer's instructions (PD SWISS). After achieving a creamy mixture, MTA shall be delivered to the pulp chamber using an amalgam carrier to a 1-2mm thickness. Using a moist pellet, it will be condensed gently over the exposed pulp stumps. Once an initial set of MTA is achieved, the access cavity shall be restored with a glass ionomer cement and composite restoration. | Procedure or surgery | Control Group with MTA pulpotomy |
| Rosemarinus officinalis extract pulpotomyA sterile cotton pellet dipped and squeezed in 6.25% aqueous extract of R-officinalis will be placed over the radicular pulp for 5 minutes. Then, the pulp chamber will be sealed with a thick paste aqueous extract of R. officinalis and zinc oxide powder. The access cavity shall be restored with glass ionomer cement and a composite restoration. | Procedure or surgery | Intervention |
Primary outcome
Pain After Intervention, Tenderness to palpation, percussion , Swelling
Time frame: Preop Post op after 1 week, 1month 3 month 6 month
The incidence and intensity of pain will be assessed postoperatively using the Visual Analogue scale. Pain intensity will be noted as no pain (0-4mm), mild pain (5-44), moderate pain (45-74mm) and severe pain (75-100mm) on a scale of 0-100mm
Periapical status after intervention
Time frame: Preop Post op 3 month 6 month
The periapical status will be assessed by using the periapical index [PAI] scoring system. Each tooth will be assigned to one of the PAI scores for the 5 categories within the scale. PAI less than or equal to 2 would be successful outcome. 1. Normal periapical structures 2. Small changes in bone structures 3. Changes in bone structure with mineral loss 4. Periodontitis with well-defined radiolucent area 5. Severe periodontitis with exacerbating features
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 27 May 2026.
- Individual participant dataSharing planned: Undecided
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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 MTA Pulpotomy and Rosemarinus officinalis extract pulpotomy in people with Irreversible Pulpitis and Pulpotomy, run by University of Health Sciences Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 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: opening soon, as of the sponsor's last update on 27 May 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 Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Zoha Nasir, BDS (+923224056794, zohanasirsheikh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain After Intervention, Tenderness to palpation, percussion , Swelling (time frame: Preop Post op after 1 week, 1month 3 month 6 month). 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?
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 27 May 2026.