Effectiveness of bioceramic for treating Acute irreversible pulpitis- Clinical and Radiographical study

Phase 2/3

Not yet recruiting

Conditions: Dental caries on pit and fissure surface,

Registration Number: CTRI/2024/12/078803

Lead Sponsor: Priyanca Panigrahi

Brief Summary: Baseline examination -This includes an intra-oral examination using a mouth mirror and probe to check the extent of caries clinically. The dental caries lesion will be identified using International Caries Detection and Assessment System (Code V and VI). The pain intensity will be assessed clinically based on the presence of Tender on Percussion and Visual Analogue Scale (VAS) along with pulp vitality using cold stimulus test where an ice stick will be placed for 3-5sec on the middle third of respected tooth. If the patient gives a positive response for the test, the next step will be assessment of radiographs that will be taken for the respective tooth to assess the carious extent and periapical changes using Orstavick et al (1986) periapical index that will be scored as follows;

1 Normal periapical structures

2 Small changes in the bone structure

3 Change in the bone structure with mineral loss

4 Periodontitis with a well-defined radiolucent area

5 Severe periodontitis with exacerbating features

**Method of application of Biodentine:**

1.After the baseline examination, disinfection of the cavity will be performed with 2.5% sodium hypochlorite followed by removal of the carious dentin, using spoon excavator Caries removal will be performed first on the margins to avoid pulpal invasion until the infected dentin is removed. The endodontic access cavity under local anesthesia will be made using a high-speed turbine with cooling water. Coronal pulp tissue will be removed using a diamond bur. The pulp chamber will be irrigated with saline solution to remove any pulp traces, and haemostasis will be performed with a gentle application of cotton dry pellet on top and repeated if required up to 6 min; bleeding time will be recorded. After maintaining a dry field for 5-10mins premixed Biodentine cement (Bio c repair) will be placed in the pulp chamber using plastic instruments followed by the placement of posterior glass ionomer cement.

2. After a follow up of 1 week with respect to outcome measures , pain will be reassessed after percussion and cold stimulus. The compatibility of the restoration will also be assessed. The radiographical assessments will be done at the intervals of 3, 6 and 9 months respectively to assess the periapical healing through radiographs using Orstavick et.al Periapical Index (1986) and scores of 3 or more will be considered as non-healing.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

20 years and above with matured pulp and co-operative 2.
Positive responses to cold stimulus and verbal pain 3.
Occlusal caries involving less than â‰¤ 2 walls of a teeth.
Teeth that can be restored.
Patients with occlusal caries of 1or 2 walled defect.

Exclusion Criteria

Non co-operative patient.
Those who deny consent to participate 3.
Teeth with open apex 4.
Negative response to cold stimulus and verbal pain.
Irreversible large bone defect and periapical changes.
Presence of sinus tract/swelling.
7.Teeth with furcation involvement and periodontal pockets.
Grossly decayed tooth and root stump.
Teeth with calcified pulp and root resorption in pre-operative radiograph.
Molars with a preoperative clinical sign of complete or partial pulp necrosis 11.
Absence of bleeding from a canal or uncontrollable pulp hemorrhage (more than 5 minutes) in at least 1 canal.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
periapical healing.	3 months \| 6 months \| 9 months
ostarvick et al radiograph criteria.	3 months \| 6 months \| 9 months

Secondary Outcome Measures

Name	Time	Method
Assesing the formation of Reparative dentine	3 months

Trial Locations

Locations (1): Institute of Dental sciences
🇮🇳
Khordha, ORISSA, India
Institute of Dental sciences
🇮🇳Khordha, ORISSA, India
Dr Priyanca Panigrahi
Principal investigator
7683879877
panigrahipriyanca@gmail.com