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

ConditionsIrreversible Pulpitis Pulpotomy MTA Vital Tooth Pulpotomy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-40

SponsorUniversity of Health Sciences Lahore

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

MTA Pulpotomy
Procedure/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 pulpotomy
Procedure/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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Control Group with MTA pulpotomyActive comparator 1 intervention

Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

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

Sponsors and contacts

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University of Health Sciences Lahore

Lead sponsor

Postgraduate Medical Institute, Lahore

Sponsor institution

Source ClinicalTrials.gov

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