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

Comparative Clinical and Radiographic Evaluation of Salvadora Persica Extract Mixed With Zn Oxide Powder Versus Mineral Trioxide Aggregate as a Pulpotomy Agent in Mature Permanent Posterior Teeth With Irreversible Pulpitis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irreversible Pulpitis
• Intervention / Treatment: Procedure: Mineral Trioxide Aggregate; Procedure: Salvadora persica Extract + Zinc Oxide

Detailed Description

Irreversible pulpitis is a common consequence of deep dental caries and represents one of the primary causes of dental pain and emergency dental visits. If left untreated, the condition may progress to pulpal necrosis and periapical pathology, ultimately resulting in tooth loss. Conventional management of irreversible pulpitis in mature permanent teeth typically involves root canal treatment (RCT), which has demonstrated high success rates. However, RCT is an invasive, technique-sensitive, time-consuming, and relatively costly procedure that requires extensive removal of tooth structure and may not always be readily accessible in resource-limited settings.

Recent advances in the understanding of pulpal healing and regeneration have led to increased interest in conservative treatment approaches such as Vital Pulp Therapy (VPT). Pulpotomy, a form of VPT, involves removal of the inflamed coronal pulp while preserving the vitality and function of the healthy radicular pulp. Emerging evidence suggests that pulpotomy can serve as a definitive treatment for mature permanent teeth diagnosed with irreversible pulpitis, provided there is no evidence of pulpal necrosis or significant periapical pathology. This approach offers several advantages, including preservation of tooth structure, reduced treatment time, lower treatment costs, and maintenance of the tooth's natural defense and proprioceptive functions.

The success of pulpotomy is largely dependent on the biological and physical properties of the medicament placed over the remaining pulp tissue. Mineral Trioxide Aggregate (MTA) is currently considered the gold standard pulpotomy material because of its excellent biocompatibility, sealing ability, antibacterial properties, and capacity to promote hard tissue formation. Despite these advantages, its widespread use is limited by high cost, prolonged setting time, difficult handling characteristics, and challenges associated with retreatment when necessary.

Salvadora persica (Miswak) is a medicinal plant that has been used traditionally for oral hygiene for centuries. It possesses well-documented antibacterial, anti-inflammatory, antioxidant, and anti-cariogenic properties. The plant contains several bioactive compounds that have demonstrated effectiveness against oral pathogens and may support tissue healing. Previous studies have investigated the use of Salvadora persica in various dental applications, including intracanal medicaments, oral hygiene products, and pulpotomy procedures in primary teeth, yielding promising outcomes. However, there is limited clinical evidence regarding its use as a pulpotomy medicament in mature permanent teeth with irreversible pulpitis.

The present randomized controlled clinical trial aims to compare the clinical and radiographic outcomes of Salvadora persica extract mixed with zinc oxide powder and Mineral Trioxide Aggregate when used as pulpotomy agents in mature permanent posterior teeth diagnosed with irreversible pulpitis. A total of 78 participants aged 18 to 40 years will be randomly allocated into two equal treatment groups. Following pulpotomy procedures, participants will be evaluated clinically and radiographically over a six-month follow-up period.

Clinical outcomes will include assessment of pain, tenderness to percussion, tenderness to palpation, swelling, sinus tract formation, and tooth mobility. Radiographic outcomes will include evaluation of periapical and inter-radicular radiolucency, internal resorption, and other signs indicative of pulpal or periapical disease progression. The primary objective is to determine whether Salvadora persica extract mixed with zinc oxide powder can achieve clinical and radiographic success rates comparable to those of MTA.

The findings of this study may provide evidence for a natural, biologically favorable, and cost-effective alternative to MTA for pulpotomy procedures. If proven effective, Salvadora persica-based pulpotomy therapy could expand access to conservative dental treatment, reduce dependence on expensive biomaterials, and support preservation of natural teeth, particularly in low-resource healthcare settings.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aniza Shahbaz, MDS; Phone Number: +92 3065364979; Email: aniza.shahbaz@gmail.com
• Study Contact Backup: Name: Shazia Naz; Email: dr.shazianaz210@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • de Montmorency college of dentistry lahore
      • Contact: Aniza Shahbaz, MDS; Phone Number: +92 3065364979; Email: aniza.shahbaz@gmail.com
      • Contact: Shazia NAZ, MDS; Phone Number: +92 3214614543; Email: dr.shazianaz210@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 1. 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.

Exclusion Criteria:

• 1. 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.

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: MTA pulpotomy group; 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; 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
Experimental: Salvadora persica-ZnO; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Success of Pulpotomy Treatment	Radiographic success will be evaluated using the Periapical Index (PAI) score and assessment of radiographic signs of pathology, including periapical radiolucency, inter-radicular radiolucency (if present), and internal resorption. Success is defined as the absence of new or progressive radiographic pathology and maintenance or improvement of periapical status.	Radiographs will be obtained preoperatively, immediately postoperatively, at 3 months, and at 6 months, with the final radiographic assessment at 6 months.

Collaborators and Investigators

• Sponsor: Postgraduate Medical Institute, Lahore

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Inorganic Chemicals; Oxides; Oxygen Compounds; Zinc Compounds; Zinc Oxide; mineral trioxide aggregate
• Other Study ID Numbers: AMC/PGMI/LGH 55/24

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