Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars With Reversible Pulpitis
2026년 7월 6일 업데이트: 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.
연구 개요
상태
모병
상세 설명
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.
연구 유형
중재적
등록 (추정된)
130
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Dr. Vinay Kumar, MDS
- 전화번호: 8901149107
- 이메일: 29vinaykr@gmail.com
연구 연락처 백업
- 이름: Dr. Vineeta Yadav, PG Student
- 전화번호: 08209485968
- 이메일: vineeta1799@gmail.com
연구 장소
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Haryana
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Rohtak, Haryana, 인도, 124001
- 모병
- PGIDS , Rohtak
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연락하다:
- Dr. Vinay Kumar, MDS
- 전화번호: 8901149107
- 이메일: 29vinaykr@gmail.com
-
연락하다:
- Dr. Vineeta, PG Student
- 전화번호: 08209485968
- 이메일: vineeta1799@gmail.com
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Success rate at 12 months
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative pain
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Dr. Vinay Kumar, MDS, PGIDS, Rohtak
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 4월 29일
기본 완료 (추정된)
2027년 10월 28일
연구 완료 (추정된)
2028년 4월 28일
연구 등록 날짜
최초 제출
2026년 7월 6일
QC 기준을 충족하는 최초 제출
2026년 7월 6일
처음 게시됨 (실제)
2026년 7월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 6일
마지막으로 확인됨
2026년 7월 1일
추가 정보
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기타 연구 ID 번호
- Vineeta
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