Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars With Reversible Pulpitis
6. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Nábor
Detailní popis
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 studie
Intervenční
Zápis (Odhadovaný)
130
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Dr. Vinay Kumar, MDS
- Telefonní číslo: 8901149107
- E-mail: 29vinaykr@gmail.com
Studijní záloha kontaktů
- Jméno: Dr. Vineeta Yadav, PG Student
- Telefonní číslo: 08209485968
- E-mail: vineeta1799@gmail.com
Studijní místa
-
-
Haryana
-
Rohtak, Haryana, Indie, 124001
- Nábor
- PGIDS , Rohtak
-
Kontakt:
- Dr. Vinay Kumar, MDS
- Telefonní číslo: 8901149107
- E-mail: 29vinaykr@gmail.com
-
Kontakt:
- Dr. Vineeta, PG Student
- Telefonní číslo: 08209485968
- E-mail: vineeta1799@gmail.com
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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)
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
|
|
Aktivní komparátor: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Success rate at 12 months
Časové okno: 12 months
|
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.
|
12 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Postoperative pain
Časové okno: Baseline and at 24 hours, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
|
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.
|
Baseline and at 24 hours, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Dr. Vinay Kumar, MDS, PGIDS, Rohtak
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
29. dubna 2026
Primární dokončení (Odhadovaný)
28. října 2027
Dokončení studie (Odhadovaný)
28. dubna 2028
Termíny zápisu do studia
První předloženo
6. července 2026
První předloženo, které splnilo kritéria kontroly kvality
6. července 2026
První zveřejněno (Aktuální)
10. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
10. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
6. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- Vineeta
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .