Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars With Reversible Pulpitis
6 lipca 2026 zaktualizowane przez: Postgraduate Institute of Dental Sciences Rohtak
Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars With Reversible Pulpitis: A Prospective Study
The aim of the study is to compare the clinical and radiographic outcomes of direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis.
Primary objective of the study is to evaluate the clinical and radiographic success of direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis.
Secondary objective of the study is to evaluate and compare postoperative pain following direct pulp capping for deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis.
Subjects of age group 18 - 40 yrs will be included and divided into two groups 1) Permanent mature molars with deep carious lesion 2) Permanent mature molars with extremely deep carious lesion.
Przegląd badań
Status
Rekrutacyjny
Szczegółowy opis
TITLE-Comparative evaluation of direct pulp capping between deep and extremely deep caries in mature permanent mandibular molars with reversible pulpitis.
PICO P (Population) -Mature permanent mandibular molars with clinical signs of reversible pulpitis.
I (Intervention) - Direct pulp capping in teeth with extremely deep carious lesion.
C (Comparison) - Direct pulp capping in teeth with deep carious lesion.
O (Outcome) - 1. Assessment of clinical success at 7 days, 6 months, 12 months and radiographic success at 6 and 12 months of follow up.
To assess pain experience at preoperative and post operatively at 24 hours intervals for one week.
Direct pulp capping is considered as the most conservative procedure to treat mechanically or traumatically exposed pulp.
In this procedure, biomaterial is directly applied on the exposed pulp.
Acc to depth of caries, carious lesion has been classified as deep caries (reaching inner quarter of dentine) and extremely deep caries (extending through entire dentine thickness).
Various studies on direct pulp capping in deep carious lesions with reversible pulpitis have reported success rates ranging from 77.3% (Mridula Parmeswaran et al 2023) to 100% (Awawdeh et al., 2018).
A prospective study by Wadhwa H. et al. (2025) demonstrated a 95.2% success rate for direct pulp capping with extremely deep carious lesions and reversible pulpitis in young individuals.
A randomized clinical trial by Taha et al. (2025), which included both deep and extremely deep carious lesions, reported a direct pulp capping success rate of 81.3%.
A recent systematic review and meta-analysis by S. Cushley et al. (2020) highlighted that the depth of caries penetration is a critical factor that need to be considered when evaluating the outcomes of direct pulp capping in cariously exposed pulps.
Currently, there is a lack of clinical trials comparing the effectiveness of direct pulp capping in cases of deep and extremely deep caries presenting with reversible pulpitis.
Hence, the present trial is designed to assess differences in clinical and radiographic outcomes of direct pulp capping between deep and extremely deep carious lesions in mature permanent teeth diagnosed with reversible pulpitis.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
130
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
- Nazwa: Dr. Vinay Kumar, MDS
- Numer telefonu: 8901149107
- E-mail: 29vinaykr@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Dr. Vineeta Yadav, PG Student
- Numer telefonu: 08209485968
- E-mail: vineeta1799@gmail.com
Lokalizacje studiów
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Haryana
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Rohtak, Haryana, Indie, 124001
- Rekrutacyjny
- PGIDS , Rohtak
-
Kontakt:
- Dr. Vinay Kumar, MDS
- Numer telefonu: 8901149107
- E-mail: 29vinaykr@gmail.com
-
Kontakt:
- Dr. Vineeta, PG Student
- Numer telefonu: 08209485968
- E-mail: vineeta1799@gmail.com
-
-
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. The patient should be 18-40 years of age. 2. Patients with deep and extremely deep caries in permanent mandibular molars. 3. Deep caries lesion -Reaching the inner quarter of dentine on radiograph 4. Extremely deep caries lesion - Caries penetrating the entire thickness of dentin on radiograph. 5. Reversible pulpitis will be diagnosed clinically based on discomfort experienced by the participant when a stimulus such as cold or sweet is applied and goes away within a couple of seconds following removal of stimulus, with no significant radiographic changes in the periapical region of the suspect tooth and pain experienced is not spontaneous. 6. Tooth should give positive response to pulp sensibility testing. 7. Bleeding can be controlled with in 8 minutes. 8. Radiographic finding of periapical index (PAI) score ≤2. 9. Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit). Exclusion criteria
- Teeth with immature roots.
- Internal/external resorption.
- Patient experience spontaneous pain.
- Negative response to vitality testing
- No pulp exposure after complete caries excavation.
- Signs of pulpal necrosis, insufficient bleeding after pulp exposure, sinus tract, swelling.
- Bleeding could not be controlled in 8 minutes.
- Pregnant women
- Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine)
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: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Direct pulp capping in extremely deep carious lesion
Direct pulp capping will be performed after establishing a clinical diagnosis of reversible pulpitis i.e. if the tooth showed symptoms triggered by cold stimuli but relieved within couple of seconds.
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After pulp exposure, pulp wound will be irrigated with 3%NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3%NaOCl over the pulpal wound for every 2 minutes till.
Hemostasis will be achieved with 3% NaOCl .The time used to control bleeding will be recorded for each tooth.
Teeth with excessive uncontrollable bleeding even after 8 mins will be excluded from the study; however, definite treatment will be provided to the patient.
Size of exposure will be measured.
After that, ProRoot MTA of 2-3 mm thickness will be applied over the lesion followed by the application of layer of RMGIC.
Then the tooth will be permanently restored with composite resin.
After restoration, a postoperative periapical radiograph will be taken using a digital imaging system for comparative evaluation after 6 months and 12 months follow up.
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Aktywny komparator: Direct pulp capping in deep carious lesion
Direct pulp capping will be performed after establishing a clinical diagnosis of reversible pulpitis i.e. if the tooth showed symptoms triggered by cold stimuli but relieved within couple of seconds.
|
After pulp exposure, pulp wound will be irrigated with 3%NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3%NaOCl over the pulpal wound for every 2 minutes.
Hemostasis will be achieved with 3% NaOCl .
The time used to control bleeding will be recorded for each tooth.
Teeth with excessive uncontrollable bleeding even after 8 mins will be excluded from the study; however, definite treatment will be provided to the patient.
Size of exposure will be measured.
After that, ProRoot MTA of 2-3 mm thickness will be applied over the lesion followed by the application of layer of RMGIC.
Then the tooth will be permanently restored with composite resin.
After restoration, a postoperative periapical radiograph will be taken using a digital imaging system for comparative evaluation after 6 months and 12 months follow up.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Success rate at 12 months
Ramy czasowe: 12 months
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Criteria for success:- Clinical: 1. Absence of signs and symptoms of spontaneous pain or pain on stimulus and discomfort except for the first few days after treatment.
2. No tenderness to palpation or percussion and the tooth is functional.
3. Normal mobility and probing pocket depth.
4. Absence of associated soft tissue swelling, sinus or fistula.
Radiographic: - 1. Absence of any periapical or interradicular radiolucency.
2. Complete radiographic healing (PAI score 1 or 2 acc. to Ostravik et al).
3. Absence of internal and external root resorption Tooth will be considered successful when all the above parameters are met.
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12 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Postoperative pain
Ramy czasowe: Baseline and at 24 hours, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
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Post Operative Pain To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line.
Score 0 means no pain and Score100 means maximum pain.
To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line.
Score 0 means no pain and Score 100 means maximum pain.
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Baseline and at 24 hours, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Dr. Vinay Kumar, MDS, PGIDS, Rohtak
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 (Rzeczywisty)
29 kwietnia 2026
Zakończenie podstawowe (Szacowany)
28 października 2027
Ukończenie studiów (Szacowany)
28 kwietnia 2028
Daty rejestracji na studia
Pierwszy przesłany
6 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
6 lipca 2026
Pierwszy wysłany (Rzeczywisty)
10 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
10 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
6 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- Vineeta
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 .
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