Pulp Capping Agent to Induce Calcific Bridge Formation.
- Conditions
- Dental caries, unspecified, (2) ICD-10 Condition: 8||Other Procedures,
- Registration Number
- CTRI/2021/09/036129
- Lead Sponsor
- Sharda University
- Brief Summary
Histological evaluation of ability of Calcium Hydroxide, Adhesive System & Platelet Rich Fibrin as pulp capping agent in inducing calcific bridge formation.
The Research will Include Fully erupted third molar in which Teeth will be mechanically cleaned and disinfected with 0.2% chlorhexidine solution.
Administration of Local Anaesthesia & Application of Rubber Dam will be done and a Class I Cavity will be prepared, after this Area measuring approximately 1-1.5 mm in diameter will be exposed under air-distilled water cooling in the centre of the pulp floor and the Bleeding will be controlled with saline irrigation and a sterile cotton pellet.
Pulp Capping of the tooth will be done using three different material and lastly will be restored using Glass Ionomer Cement and Composite resin.
Evaluation of pulp status based on patient-reported symptoms using a verbal pain intensity scale, clinical examinations, and thermal and electrical tests.
The clinical assessment after 1 week and after 6 weeks of observation, directly before tooth extraction.
Extraction of the teeth with minimal trauma only after all the parameters have been satisfied.
The extracted teeth will then be subjected to Histological analysis on the H&E stained specimens using an optical microscope.
4. Research objectives.
· To evaluate the ability of Calcium Hydroxide as pulp capping agent in inducing calcific bridge formation.
· To evaluate the ability of Adhesive System as pulp capping agent in inducing calcific bridge formation.
· To evaluate the ability of Platelet Rich Fibrin as pulp capping agent in inducing calcific bridge formation.
· To evaluate & compare the ability of Calcium Hydroxide, Adhesive System and Platelet Rich Fibrin as Pulp capping agent in inducing calcific bridge formation.
5. Research methodology (detailed description of the materials and methods).
Sample size - Thirty fully erupted maxillary, and mandibular third molars from patients.
Radiographic Examination will be done to exclude the presence of caries or periapical pathology.
Use of Electric Pulp Tester to check the vitality of the pulp.
Teeth will be mechanically cleaned and disinfected with 0.2% chlorhexidine solution.
Administration of Local Anaesthesia & Application of Rubber Dam
Preparation of Conventional occlusal Class I Cavities under air-distilled water cooling using round diamond bur (ISO Size 012).
Area measuring approximately 1-1.5 mm in diameter will be exposed under air-distilled water cooling in the centre of the pulp floor using round carbide bur (ISO Size 012).
Bleeding will be controlled with saline irrigation and a sterile cotton pellet. And Pulp capping will be done using three different materials:
Group 1: Calcium Hydroxide
Group 2: Adhesive System
Group 3: Platelet Rich Fibrin
After Pulp Capping the tooth is restored using Glass Ionomer Cement and Composite resin.
Evaluation of pulp status based on patient-reported symptoms using a verbal pain intensity scale, clinical examinations, and thermal and electrical tests.
The clinical assessment after 1 week and after 6 weeks of observation, directly before tooth extraction.
Pain will be assessed using verbal pain intensity scale, which is a list of verbal descriptors defining pain, such as the following:
Absent, weak, moderate, and strong.
To analyze the duration of pain, we used the following classification:
0, no pain; 1, symptoms lasting for one day; 2, symptoms lasting for 2–7 days; 3, symptoms lasting longer than 7 days.
An electrical test using Electrical Pulp Tester. (Repeated 3 times)
Radiographic Examination in order to evaluate the status of the periapical tissues, presence of deposits in the pulp chamber, and the presence of internal or external resorption.
Extraction of the teeth with minimal trauma.
The extracted teeth will be fixed in 10% buffered formalin solution.
Demineralization in nitric acid, and embedded in paraffin.
Two- to 3-micron thick serial sections, cut in the lingual-buccal plane, will be stained with haematoxylin and eosin (H&E).
Bacterial detection using the Brown and Brenn technique.
Histological analysis on the H&E stained specimens using an optical microscope.
Investigations of the sectioning under normal and ultraviolet (UV) light using 38 HE eGFP (which will clearly illustrate the physiological secondary dentin and the original dentin) and 43 HE Cy3 filters (clearly illustrating the kernel odontoblasts and blood cell counts).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 30
- Thirty fully erupted maxillary and mandibular third molars of patients.
- Indicated for extraction for orthodontic or surgical purpose.
Dental caries, cracks, developmental defects, fractured and restored teeth.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate & compare the ability of Calcium Hydroxide, Adhesive System and Platelet Rich Fibrin as Pulp capping agent in inducing calcific bridge formation. 2years
- Secondary Outcome Measures
Name Time Method To evaluate the ability of Calcium Hydroxide as pulp capping agent in inducing calcific bridge formation. To evaluate the ability of Adhesive System as pulp capping agent in inducing calcific bridge formation.
Trial Locations
- Locations (1)
Department of Conservative dentistry and Endodontics,SDS, Sharda University
🇮🇳Nagar, UTTAR PRADESH, India
Department of Conservative dentistry and Endodontics,SDS, Sharda University🇮🇳Nagar, UTTAR PRADESH, IndiaDr Ekta ChoudharyPrincipal investigator9818452508ekta.choudhary@sharda.ac.in