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Irreversible PulpitisNCT07630181

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

A study testing Mineral Trioxide Aggregate and Salvadora persica Extract + Zinc Oxide in people with Irreversible Pulpitis, run by Postgraduate Medical Institute, Lahore at 1 site in Pakistan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Irreversible Pulpitis
What is being tested?
Mineral Trioxide Aggregate and Salvadora persica Extract + Zinc Oxide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 sitePakistan
Study dates
20 Jun 2026to 20 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aniza Shahbaz, MDS contact

+92 3065364979

aniza.shahbaz@gmail.com

Shazia Naz contact

dr.shazianaz210@gmail.com

Pakistan1 site
  • de Montmorency college of dentistry lahore

    Lahore, Punjab Province, 54000

    Aniza Shahbaz, MDS, +92 3065364979, aniza.shahbaz@gmail.com

    Shazia NAZ, MDS, +92 3214614543, dr.shazianaz210@gmail.com

Other trials in Pakistan

About this study

Official title: 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.

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.

Being tested
Mineral Trioxide Aggregate, Salvadora persica Extract + Zinc Oxide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mineral Trioxide AggregateProcedure or surgery

    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

  • Salvadora persica Extract + Zinc OxideProcedure or surgery

    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.

Study groups in NCT07630181
Study groupRoleWhat they receive
MTA pulpotomy groupActive comparatorParticipants 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.
Receives: Procedure: Mineral Trioxide Aggregate
Salvadora persica-ZnOExperimentalParticipants 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.
Receives: Procedure: Salvadora persica Extract + Zinc Oxide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study start20 Jun 2026 (estimated)
  3. Primary completion20 Sep 2026 (estimated)
  4. Study completion20 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07630181
Sponsor's protocol ID
AMC/PGMI/LGH 55/24
Status last verified
Jun 2026
First submitted
1 Jun 2026
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Mineral Trioxide Aggregate and Salvadora persica Extract + Zinc Oxide in people with Irreversible Pulpitis, run by Postgraduate Medical Institute, Lahore at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aniza Shahbaz, MDS (+92 3065364979, aniza.shahbaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Success of Pulpotomy Treatment (time frame: Assessed at 1 week, 1 month, 3 months, and 6 months post-treatment, with the primary endpoint at 6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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