Bioactive Materials in Vital Pulp Therapy of Permanent Teeth
Evaluation of the Effect of Two Different Bioactive Materials on the Success of Vital Pulp Therapy in Permanent Teeth: A Prospective Clinical Study
This randomized clinical study aimed to evaluate and compare the clinical, radiographic, and postoperative pain outcomes of direct pulp capping performed using two calcium silicate-based materials: ProRoot MTA and Biofactor MTA in permanent teeth with vital pulp exposure.
A total of 80 teeth were randomly allocated into two groups according to the capping material used. Following standardized caries removal and achievement of hemostasis, direct pulp capping was performed using either ProRoot MTA or Biofactor MTA under similar clinical conditions. Definitive coronal restorations were completed 24 hours after the procedure.
Postoperative pain was assessed using a numerical rating scale (NRS) at 0, 6, 12, 24, and 48 hours after treatment. Patients were instructed to record their pain levels and analgesic intake during this period.
Patients were recalled for clinical and radiographic evaluations at 6 and 12 months. Clinical success was defined as the absence of spontaneous pain, sensitivity, swelling, sinus tract formation, and tenderness to percussion or palpation. Radiographic success was determined by the absence of periapical pathology.
Additionally, the influence of demographic and clinical variables, including age, gender, characteristics of pulp exposure, and intraoperative factors, on treatment outcomes and pulpal healing was evaluated.
연구 개요
상태
정황
상세 설명
This randomized controlled clinical study was designed to evaluate and compare the clinical performance, radiographic outcomes, postoperative pain, and pulpal healing following direct pulp capping using two calcium silicate-based materials: ProRoot MTA and Biofactor MTA in permanent teeth with vital pulp exposure.
A total of 80 teeth diagnosed with vital pulp requiring direct pulp capping were included in the study. Participants were randomly allocated into two equal groups (n=40) according to the pulp capping material used. All procedures were carried out under standardized clinical conditions.
Caries removal was performed using a sterile round diamond bur under water cooling, followed by excavation with a spoon excavator. Teeth with pulp exposure were included in the study. Hemostasis was achieved. In cases where bleeding could not be controlled within a clinically acceptable time, the tooth was excluded from the study.
In the experimental group, Biofactor MTA was applied directly over the exposed pulp tissue according to the manufacturer's instructions. In the control group, ProRoot MTA was used following the same protocol. After placement of the capping material, a protective base was applied, and the cavity was temporarily restored. Definitive coronal restorations were completed 24 hours after the initial procedure.
Postoperative pain was evaluated using a Numerical Rating Scale (NRS) at 0, 6, 12, 24, and 48 hours following treatment. Patients were instructed to record their pain intensity and the number of analgesic tablets taken during this period.
Patients were recalled for follow-up examinations at 6 and 12 months. Clinical evaluation included assessment of spontaneous pain, sensitivity, swelling, sinus tract formation, tenderness to percussion and palpation, and periodontal probing depths. Radiographic evaluation was performed to assess the presence of periapical pathology.
Treatment success was defined as the absence of clinical symptoms and the absence of radiographic signs of pathology.
Furthermore, the influence of demographic and clinical variables, including age, gender, number and location of pulp exposures, size of exposure, and bleeding control time, on treatment outcomes was analyzed.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Izmir, 터키 (Türkiye), 35100
- Ege University Faculty of Dentistry
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged between 13 and 65 years
- Patients with adequate patient-clinician communication
- Patients who agree to attend periodic follow-up visits throughout the study
- Patients who provide written informed consent to participate in the study
- Systemically healthy patients
- Teeth with no previous endodontic treatment
- Teeth showing a positive response to cold and electric pulp test
- Permanent teeth
- Posterior teeth
- Teeth that can be restored with direct composite restoration
- Teeth with pulp exposure (pulpal perforation)
- Presence of bleeding from the exposed pulp that can be controlled within 5-10 minutes
Exclusion Criteria:
- Patients who refuse to participate in the study
- Medically compromised patients (e.g., patients with systemic diseases, immunological disorders, or those using medications)
- Patients with known allergies to materials used during vital pulp therapy
- Pregnant patients
- Non-vital teeth
- Presence of advanced periodontal disease (probing depth > 3 mm)
- Teeth with previous endodontic treatment
- Teeth with insufficient remaining tooth structure that cannot be restored with restorative materials
- Teeth where adequate isolation cannot be achieved
- Teeth requiring post core restoration
- Patients in whom periapical radiographs cannot be obtained
- Patients unable to attend follow-up visits
- Cases in which bleeding from the exposed pulp cannot be controlled within 5-10 minutes
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: ProRoot MTA
In this group, direct pulp capping procedures were performed using ProRoot MTA.
Following caries removal under water cooling with a sterile round diamond bur and spoon excavator, teeth with pulp exposure were included in the study.
Hemostasis was achieved.
ProRoot MTA was then placed directly over the exposed pulp tissue according to the manufacturer's instructions.
A protective base was applied over the material, and the cavity was temporarily restored.
Definitive coronal restoration was completed 24 hours after the procedure.
|
Direct pulp capping was performed using ProRoot MTA after caries removal and hemostasis.
The material was placed over the pulp exposure, and definitive restoration was completed after 24 hours.
|
|
실험적: BIOfactor MTA
In this group, direct pulp capping procedures were performed using BIOfactor MTA.
Following caries removal under water cooling with a sterile round diamond bur and spoon excavator, teeth with pulp exposure were included in the study.
Hemostasis was achieved.
BIOfactor MTA was placed over the exposure site in accordance with the manufacturer's recommendations.
A protective base material was applied, and temporary restoration was performed.
Permanent coronal restoration was completed 24 hours later.
|
Direct pulp capping was performed using Biofactor MTA following caries removal and hemostasis.
The material was applied directly over the exposed pulp, and definitive restoration was completed after 24 hours.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical and radiographic success of direct pulp capping
기간: 1 year follow-up
|
Treatment success defined as the absence of clinical symptoms, including spontaneous pain, sensitivity, swelling, sinus tract formation, and tenderness to percussion or palpation, together with the absence of radiographic signs of pathology such as periapical radiolucency.
|
1 year follow-up
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative pain intensity following direct pulp capping
기간: up to 2-day
|
Postoperative pain will be evaluated using a Numerical Rating Scale (NRS), where patients rate their pain intensity at predefined time intervals after treatment.
The Numerical Rating Scale is a pain measurement scale that encompasses the following grades: 0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain.
Patients will be instructed to record their pain levels and analgesic intake.
|
up to 2-day
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Gözde Kandemir Demirci, Associate Professor, Ege University Faculty of Dentistry
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 24-3.1/5
- 32695 (기타 보조금/기금 번호: Ege University Scientific Research Projects Coordination Unit (BAP))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .