R. Officinalis as Pulpotomy Agent in Permanent Teeth With Irreversible Pulpitis

NCT07610057 | Not Yet Recruiting DMC

• 1 other identifier: 60/24
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Irreversible Pulpitis; Pulpotomy; MTA Vital Tooth Pulpotomy

Keywords

pulpotomy; rosemarinus officinalis; MTA; permanent teeth with irreversible pulpitis; Vital pulp theray

Outcome Measures

Primary Outcomes (2)

• 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

  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. 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

  Preop Post op 3 month 6 month

Study Arms (2)

Control Group with MTA pulpotomy

ACTIVE COMPARATOR

Pulpotomy Medicaent in control group

Procedure: MTA Pulpotomy

Intervention

EXPERIMENTAL

R. officinalis as pulpotomy medicament

Procedure: Rosemarinus officinalis extract pulpotomy

Interventions

MTA Pulpotomy PROCEDURE

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.

Control Group with MTA pulpotomy

Rosemarinus officinalis extract pulpotomy PROCEDURE

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (1)

Punjab Dental Hospital, Lahore .

Lahore, Punjab Province, 54000, Pakistan

Location

Central Study Contacts

Zoha Nasir, BDS

CONTACT

+923224056794; zohanasirsheikh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

PA (1)