Effect of MTA apical filling and full obturation of canal on healing of large periapical pathology.

Recruiting

• Conditions: Disturbances in tooth formation,; Subjects with anterior teeth with open apex and periapical lesion

• Registration Number: CTRI/2023/03/051008
• Lead Sponsor: PGIMER

Brief Summary

The prospective, randomized, double blinded study will be carried out on 30 nonvital, immature permanent maxillary incisor teeth randomly selected from dental OPD. Sample size determination is based on a level type I error at 0.05 and b level type II error of 0.20.  We assume a dropout rate of approximately 15% and would enroll at least 10 subjects in each group.  Diagnosis will be made based on the presence of sinus tract, spontaneous pain and/or pain to percussion or palpation. Periapical radiographs will be taken to confirm the presence of open apex and a  periapical lesion. Then CBCT analysis will be done to note the size of the lesion.

An informed written consent will be obtained from each subject. Samples will be allotted into three groups –

 Group I – 10 teeth obturated with MTA

 Group II- 10 teeth in which apexification will be done with MTA and the remaining canal will be obturated with thermoplasticised gutta percha.

 Group III-10 teeth as control (cleaning and shaping will be done but will not be obturated)

The remaining canal will be obturated using thermaplasticized guttapercha points in  group II  after radiographic confirmation of the apical barrier whereas in  group I, obturation will be carried out with MTA on same day. The access cavity will be restored with the temporary restorative material (Cavitâ„¢ ESPE, Cergy Pontoise, France) and radiograph will be taken to confirm the extension/condensation of MTA apical plug and obturation. The clinical and radiographic evaluation will be  carried out at a follow up period of 3, 6 and12  months and success rate will be determined based upon the time duration required for periapical healing.

 Follow up will be done after 12  months using CBCT to note the time taken for healing.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-03-22
• Study Start: 2023-04-20

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Maxillary/Mandibular anterior teeth with lesion size score of 4 as per CBCT periapical index scores will be selected.
• Age group will be from 15-30 years.

Exclusion Criteria

pregnant patients -patients with a history of therapeutic radiation to head and neck.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CBCT analysis of time taken for periapical healing with MTA apexification and obturation technique in open apex teeth with large periapical lesion.	CBCT analysis of time taken for periapical healing with MTA apexification and obturation technique in open apex teeth with large periapical lesion.follow up will be done at 3,6 and 12 months.

Secondary Outcome Measures

Name	Time	Method
•Periapical healing with MTA apexification in open apex teeth with large periapical lesion.	•Periapical healing with MTA obturation in open apex teeth with large periapical lesion.

Trial Locations

Locations (1)

Post Graduate Institute of Medical Education and Research CHANDIGARH; 🇮🇳 Chandigarh, CHANDIGARH, India

Post Graduate Institute of Medical Education and Research CHANDIGARH

🇮🇳Chandigarh, CHANDIGARH, India

DR PRABHLEEN KAUR BRAR

Principal investigator

09878030178

prabhleen_brar@yahoo.com