Salvadora Persica-Zinc Oxide Versus MTA as Pulpotomy Agents in Mature Permanent Molars With Irreversible Pulpitis

NCT07630181 | Not Yet Recruiting

• 1 other identifier: AMC/PGMI/LGH 55/24
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Pulpotomy has emerged as a conservative treatment option for mature permanent teeth with irreversible pulpitis, aiming to preserve pulp vitality while avoiding the limitations of conventional root canal treatment. Mineral Trioxide Aggregate (MTA) is currently considered the gold standard pulpotomy medicament because of its favorable biological properties; however, its high cost, difficult handling characteristics, and prolonged setting time limit its widespread use. Salvadora persica (Miswak), a medicinal plant with documented antibacterial and anti-inflammatory properties, may provide a cost-effective biological alternative. This randomized controlled clinical trial aims to compare the clinical and radiographic outcomes of Salvadora persica extract mixed with zinc oxide powder versus MTA as pulpotomy agents in mature permanent posterior teeth diagnosed with irreversible pulpitis. A total of 78 patients aged 18-40 years will be randomly allocated into two equal treatment groups. Clinical outcomes, including pain, tenderness to percussion and palpation, swelling, sinus tract formation, and tooth mobility, will be evaluated alongside radiographic outcomes such as periapical/inter-radicular radiolucency and internal resorption. Participants will be followed for six months after treatment. The study seeks to determine whether Salvadora persica extract mixed with zinc oxide powder can provide outcomes comparable to MTA. If successful, this natural and economical material may offer an accessible alternative for vital pulp therapy, particularly in low-resource settings, promoting tooth preservation and reducing the need for more invasive endodontic procedures.

Conditions

Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Clinical Success of Pulpotomy Treatment

  Clinical success will be assessed by the absence of pain (measured using a 0-100 mm Visual Analogue Scale), tenderness to percussion, tenderness to palpation, swelling, sinus tract formation, and abnormal tooth mobility following pulpotomy treatment.

  Assessed at 1 week, 1 month, 3 months, and 6 months post-treatment, with the primary endpoint at 6 months.

Secondary Outcomes (1)

• Radiographic Success of Pulpotomy Treatment

  Radiographs will be obtained preoperatively, immediately postoperatively, at 3 months, and at 6 months, with the final radiographic assessment at 6 months.

Study Arms (2)

MTA pulpotomy group

ACTIVE COMPARATOR

Participants will undergo pulpotomy in mature permanent posterior teeth diagnosed with irreversible pulpitis. Following removal of the coronal pulp, Mineral Trioxide Aggregate (MTA) will be placed over the radicular pulp before definitive restoration.

Procedure: Mineral Trioxide Aggregate

Salvadora persica-ZnO

EXPERIMENTAL

Participants will undergo pulpotomy in mature permanent posterior teeth diagnosed with irreversible pulpitis. Following removal of the coronal pulp, a mixture of Salvadora persica extract and zinc oxide powder will be placed over the radicular pulp before definitive restoration.

Procedure: Salvadora persica Extract + Zinc Oxide

Interventions

Mineral Trioxide Aggregate PROCEDURE

Mineral Trioxide Aggregate (MTA) will be applied directly over the amputated radicular pulp tissue as the pulpotomy medicament according to the manufacturer's instructions. MTA serves as the reference standard material because of its established biocompatibility, sealing ability, and capacity to promote hard tissue formation

MTA pulpotomy group

Salvadora persica Extract + Zinc Oxide PROCEDURE

Salvadora persica extract will be mixed with zinc oxide powder to form a paste and applied directly over the amputated radicular pulp tissue as the pulpotomy medicament. The material is intended to provide antibacterial, anti-inflammatory, and pulp-healing effects while preserving pulp vitality.

Salvadora persica-ZnO

Eligibility Criteria

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

You may qualify if:

• \. Co-operative healthy patients both male and female with age ranging from 18-40 years. 2. Mature permanent molar teeth with caries extending deep into dentine more than two third on bite wing x ray 3. Teeth with clinical signs and symptoms of irreversible pulpitis i.e. spontaneous lingering pain that can be reproduced with a cold test 4. Teeth not painful to percussion and palpation. 5. Teeth in which hemostasis can be achieved within 5 mins. If not achieved individual will be excluded from the study 6. No peri-apical rarefaction, and inter-radicular rarefaction as seen on periapical x-ray.

You may not qualify if:

• \. Small carious lesion or lesions not extending deep into dentine closer to pulp 2. Grossly carious teeth with necrosed pulp 3. Teeth with swelling, abscess and sinus tract. 4. Periodontally compromised teeth 5. Immature permanent teeth with open apex 6. Fractured teeth 7. Teeth with signs of internal or external resorption 8. Patients with systemic diseases i.e. ASA classification III, IV and V will be excluded.

Sponsors & Collaborators

• Postgraduate Medical Institute, Lahore: lead

Study Sites (1)

de Montmorency college of dentistry lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Interventions

mineral trioxide aggregate; Zinc Oxide

Intervention Hierarchy (Ancestors)

Oxides; Oxygen Compounds; Inorganic Chemicals; Zinc Compounds

Central Study Contacts

Aniza Shahbaz, MDS

CONTACT

+92 3065364979; aniza.shahbaz@gmail.com

Shazia Naz

CONTACT

dr.shazianaz210@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MDS Resident Operative Dentistry Department

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: June 20, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

PA (1)