CClinicalTrials.gg
Not yet recruitingNCT07610057Updated May 27, 2026

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

An interventional study of MTA Pulpotomy and Rosemarinus officinalis extract pulpotomy in Irreversible Pulpitis, Pulpotomy and MTA Vital Tooth Pulpotomy, sponsored by University of Health Sciences Lahore. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by University of Health Sciences Lahore · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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

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.

02

Conditions studied

  • Irreversible Pulpitis
  • Pulpotomy
  • MTA Vital Tooth Pulpotomy

Keywords

  • pulpotomy
  • rosemarinus officinalis
  • MTA
  • permanent teeth with irreversible pulpitis
  • Vital pulp theray
03

In context

Lead sponsor

University of Health Sciences Lahore is the lead sponsor of 77 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Control Group with MTA pulpotomy

    Pulpotomy Medicaent in control group

    Procedure: MTA Pulpotomy

  • Experimental
    Intervention

    R. officinalis as pulpotomy medicament

    Procedure: Rosemarinus officinalis extract pulpotomy

Interventions

  • ProcedureMTA 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.

  • ProcedureRosemarinus 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Preop Post op after 1 week, 1month 3 month 6 month

  2. 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

    Time frame: Preop Post op 3 month 6 month

07

Study locations

1 site
  • Punjab Dental Hospital, Lahore .
    Lahore, Punjab Province 54000, Pakistan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07610057
Lead sponsor
University of Health Sciences Lahore
Responsible party
Zoha Nasir (Principal Investigator, Postgraduate Medical Institute, Lahore) — Principal investigator
First posted
May 27, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 27, 2026

Study contacts

Zoha Nasir, BDS
Contact
zohanasirsheikh@gmail.com
+923224056794

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion