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

1 czerwca 2026 zaktualizowane przez: Aniza Shahbaz, Postgraduate Medical Institute, Lahore

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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

78

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
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
Eksperymentalny: 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.
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Clinical Success of Pulpotomy Treatment
Ramy czasowe: Assessed at 1 week, 1 month, 3 months, and 6 months post-treatment, with the primary endpoint at 6 months.
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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Radiographic Success of Pulpotomy Treatment
Ramy czasowe: Radiographs will be obtained preoperatively, immediately postoperatively, at 3 months, and at 6 months, with the final radiographic assessment at 6 months.
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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

20 czerwca 2026

Zakończenie podstawowe (Szacowany)

20 września 2026

Ukończenie studiów (Szacowany)

20 grudnia 2026

Daty rejestracji na studia

Pierwszy przesłany

1 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

5 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • AMC/PGMI/LGH 55/24

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Mineral Trioxide Aggregate

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