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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Irreversible Pulpitis; Pulpotomy; MTA Vital Tooth Pulpotomy
• Intervention / Treatment: Procedure: MTA Pulpotomy; Procedure: Rosemarinus officinalis extract pulpotomy

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zoha Nasir, BDS; Phone Number: +923224056794; Email: zohanasirsheikh@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Punjab Dental Hospital, Lahore .

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group with MTA pulpotomy; Pulpotomy Medicaent in control group	Procedure: MTA Pulpotomy; 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.
Experimental: Intervention; R. officinalis as pulpotomy medicament	Procedure: Rosemarinus officinalis extract pulpotomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.; 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	Preop Post op 3 month 6 month

Collaborators and Investigators

• Sponsor: University of Health Sciences Lahore

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pulpotomy; MTA; rosemarinus officinalis; permanent teeth with irreversible pulpitis; Vital pulp theray
• Other Study ID Numbers: 60/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No