A clinical trial in testing a new way to treat infected mature teeth.
- Conditions
- Health Condition 1: K04- Diseases of pulp and periapical tissues
- Registration Number
- CTRI/2024/02/062552
- Lead Sponsor
- REZVANA BEGUM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Nonvital single rooted maxillary anterior tooth with a mature root and a periapical lesion with a periapical index score equal to or more than 3 according to the classification of orstavik et al 1986
Radiologic confirmation of a single rooted necrotic tooth with a single root canal
Teeth with severe coronal defects that require post and core as final restoration
Non-restorable teeth
Presence of other pathological root resorption
Teeth with previous root canal treatment
Presence of periodontitis
Pregnant or lactating females
A history of systemic diseases or any allergies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is obtained by evaluating the clinical and radiographic outcomes <br/ ><br>Success <br/ ><br>After REP <br/ ><br>the tooth is asymptomatic absence of percussion pain sinus or fistula <br/ ><br>The radiographic examination demonstrates the absence or reduced apical shadow <br/ ><br>Failure <br/ ><br>After REP <br/ ><br>the tooth is symptomatic with symptoms of apical infection such as pain and fistula <br/ ><br>The radiographic examination demonstrates a new onset apical shadow or an enlarged apical shadow <br/ ><br>Timepoint: Baseline 3month 6month 12month
- Secondary Outcome Measures
Name Time Method The secondary outcomes include the subjective response from the patient to thermal & electric <br/ ><br>stimuli, which reflects the responsiveness of regenerative pulpal sensory neurons. <br/ ><br>POSITIVE RESPONSE NORMAL RESPONSE The test tooth is considered normal if <br/ ><br>the patient responds similarly to when a control <br/ ><br>tooth is tested <br/ ><br>NO RESPONSE The tested tooth is considered to have no response if the patient does not <br/ ><br>respond to stimulation <br/ ><br>Timepoint: Baseline 3month 6month 12month