Root canal treatment without obturation with regenerative technique

Recruiting

Conditions: Periapical pathologies associated with infected,non-vital mature, permanent teeth

Registration Number: CTRI/2012/11/003102

Lead Sponsor: Indian Council of Medical Research ICMR

Brief Summary: To evaluate and compare the healing response following novel, non-obturation endodontic treatment and the conventional endodontic treatment protocol by clinical and radiographic evaluation with pre and post treatment digital intra-oral X-ray and Cone Beam Computed Tomography (CBCT).xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

192 cases of at least 2 periapically infected teeth will be included in the study (Sample calculation shown in Materials and methods). Ethical clearance and informed consent of the patient will be taken. Inclusion and exclusion criteria will be laid down and followed. One of the affected teeth will be treated by conventional endodontic procedure of cleaning, shaping, disinfection, obturation and coronal seal. The other tooth will be treated by the novel treatment protocol. Pretreatment digital intraoral periapical X rays and CBCT will be taken. The cases will be followed up at 3, 6 months, 1, 1 Â½ and 2 years and evaluated clinically and radiographically. Post treatment CBCT will be taken only at 6-months interval. The data will be analyzed and healing response will be compared in the two groups.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 192

Inclusion Criteria

Cases presenting with clinical or radiographic signs and symptoms of periapical pathologies, irrespective of age and sex will be included in the study.

Exclusion Criteria

Patients having any systemic disease, which can compromise the healing response such as diabetes, patients on excessive medications, on immuno-suppressants, those receiving RT or CT etc.
will not be included.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete control and resolution of clinical signs	followed up at 3, 6 months, 1, 1 Â½ and 2 years
and symptoms of periapical disease, such as	followed up at 3, 6 months, 1, 1 Â½ and 2 years
pain, swelling, inflammation and restoration of	followed up at 3, 6 months, 1, 1 Â½ and 2 years
function	followed up at 3, 6 months, 1, 1 Â½ and 2 years
Radiographic evidence of healing of periapical	followed up at 3, 6 months, 1, 1 Â½ and 2 years
lesions showing disappearance or reduction in	followed up at 3, 6 months, 1, 1 Â½ and 2 years
size of the lesion or atleast arrest of lesion size	followed up at 3, 6 months, 1, 1 Â½ and 2 years
(not increasing)	followed up at 3, 6 months, 1, 1 Â½ and 2 years

Secondary Outcome Measures

Name	Time	Method
Formation of a natural, biological seal of	mineralized tissue at the root apices

Trial Locations

Locations (1): Department of Conservative Dentistry and Endodontics, 3rd Floor, CDER
🇮🇳
South, DELHI, India
Department of Conservative Dentistry and Endodontics, 3rd Floor, CDER
🇮🇳South, DELHI, India
Dr Naseem Shah
Principal investigator
naseemys@gmail.com