Biodentine vs Calcium Hydroxide for Pulp Capping in Mature Permanent Teeth
Biodentine - Indirect Pulp Capping
+ Calcium Hydroxide - Indirect Pulp Capping
Treatment Study
Summary
Study start date: February 5, 2023
Actual date on which the first participant was enrolled.The study is focused on comparing two materials, Biodentine and Calcium Hydroxide, used in a dental procedure called indirect pulp capping. This procedure helps preserve the health of the tooth's nerve when there are deep cavities but no direct exposure of the nerve. Calcium Hydroxide has been a traditional choice but has some drawbacks such as poor adhesion and solubility. Biodentine, a newer material, shows promise with better sealing ability and strength. The study targets adults aged 20 to 45 with specific dental conditions, aiming to find out which material better maintains tooth health by reducing pain and preventing further dental issues. Participants in the study undergo a specific dental treatment where the cavity is cleaned, and then either Biodentine or Calcium Hydroxide is applied to the tooth. After a week, the tooth is further treated with a filling material, and the process is completed with a final restoration. The effectiveness of the treatment is evaluated over the course of 12 weeks through follow-up visits assessing pain levels, tooth sensitivity, and x-rays to check for any issues. The study carefully monitors participants to ensure safety and aims to identify the most effective material for preserving tooth health.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.76 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 20 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: Participants must meet all of the following criteria to be included in the study: * Age: 20 to 45 years. * Tooth Type: Mature permanent teeth (maxillary or mandibular). * Caries Status: Occlusal carious lesions without previous restorations. * Pulpal Diagnosis: Reversible pulpitis confirmed by: * Patient history and clinical examination * Positive response to thermal (cold) and electric pulp tests * No tenderness to percussion * Radiographic Assessment: Carious lesion corresponding to ICDAS radiographic score RC-5. * Periapical Status: No signs of periapical radiolucency or root resorption on radiograph. Exclusion Criteria: * Participants will be excluded if they meet any of the following: * Teeth exhibiting signs of irreversible pulpitis or pulp necrosis. * Tenderness to percussion on clinical examination. * Pulp exposure during caries removal. * Systemic conditions that may interfere with healing or immune response, including: Chronic systemic illness Immunocompromised status Pregnancy -Third molars (due to anatomical and treatment variability)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location