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Not yet recruitingNCT07630181Updated Jun 5, 2026

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

An interventional study of Mineral Trioxide Aggregate and Salvadora persica Extract + Zinc Oxide in Irreversible Pulpitis, sponsored by Postgraduate Medical Institute, Lahore. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Postgraduate Medical Institute, Lahore · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Irreversible Pulpitis

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03

In context

Pulpitis

316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.

This study's planned enrollment of 78 is above the median of 64 across 288 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

Postgraduate Medical Institute, Lahore is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

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

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Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. III, IV and V will be excluded.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

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Study design

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

Study arms

  • 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

  • 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

Interventions

  • ProcedureMineral 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

  • ProcedureSalvadora 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.

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What researchers measure

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.

    Time frame: 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

    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.

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

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Sep 2026, 3 months later.

Of 158 non-industry interventional studies with no phase under Pulpitis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 28. This study's planned 3 months is below that.

Counting every sponsor, half of 158 studies reached it within 16 months; a quarter within 9 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 1, 2026
First posted
Jun 5, 2026
StartEst.
Jun 20, 2026
Primary completionEst.
Sep 20, 2026
CompletionEst.
Dec 20, 2026
Last update
Jun 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07630181
Lead sponsor
Postgraduate Medical Institute, Lahore
Responsible party
Aniza Shahbaz (MDS Resident Operative Dentistry Department, Postgraduate Medical Institute, Lahore) — Principal investigator
First posted
Jun 5, 2026
Start date
Jun 20, 2026 (estimated)
Primary completion
Sep 20, 2026 (estimated)
Completion
Dec 20, 2026 (estimated)
Last update
Jun 5, 2026

Study contacts

Aniza Shahbaz, MDS
Contact
aniza.shahbaz@gmail.com
+92 3065364979
Shazia Naz
Contact
dr.shazianaz210@gmail.com

Oversight

Data monitoring committee
No
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 Jun 2026. You cannot join it, but the record below documents what was studied.

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