A clinical trial in testing a new way to treat infected mature teeth.

Regenerative endodontic procedures for treatment of necrotic mature teeth with periapical lesions - a randomized controlled trial - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062552

Enrollment

Registered

2024-02-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K04- Diseases of pulp and periapical tissues

Interventions

Intervention1: REGENERATIVE ENDODONTIC PROCEDURE WITH BLOOD CLOT: According to AAE First appointment involves infection control and inflammation relief Second appointment pulp regeneration and revasc

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The primary outcome is obtained by evaluating the clinical and radiographic outcomes Success After REP the tooth is asymptomatic absence of percussion pain sinus or fistula The radiographic examination demonstrates the absence or reduced apical shadow Failure After REP the tooth is symptomatic with symptoms of apical infection such as pain and fistula The radiographic examination demonstrates a new onset apical shadow or an enlarged apical shadow Timepoint: Baseline 3month 6month 12month	—

Measure

Time frame

The primary outcome is obtained by evaluating the clinical and radiographic outcomes Success After REP the tooth is asymptomatic absence of percussion pain sinus or fistula The radiographic examination demonstrates the absence or reduced apical shadow Failure After REP the tooth is symptomatic with symptoms of apical infection such as pain and fistula The radiographic examination demonstrates a new onset apical shadow or an enlarged apical shadow Timepoint: Baseline 3month 6month 12month

—

Secondary

Measure	Time frame
The secondary outcomes include the subjective response from the patient to thermal & electric stimuli, which reflects the responsiveness of regenerative pulpal sensory neurons. POSITIVE RESPONSE NORMAL RESPONSE The test tooth is considered normal if the patient responds similarly to when a control tooth is tested NO RESPONSE The tested tooth is considered to have no response if the patient does not respond to stimulation Timepoint: Baseline 3month 6month 12month	—

Measure

Time frame

The secondary outcomes include the subjective response from the patient to thermal & electric stimuli, which reflects the responsiveness of regenerative pulpal sensory neurons. POSITIVE RESPONSE NORMAL RESPONSE The test tooth is considered normal if the patient responds similarly to when a control tooth is tested NO RESPONSE The tested tooth is considered to have no response if the patient does not respond to stimulation Timepoint: Baseline 3month 6month 12month

—

Countries

India

Contacts

Public ContactM S REZVANA BEGUM

Rajah muthiah dental college and hospital

speciality2001@gmail.com9487442339

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026