Clinical survival of root canal treated teeth restored with reinforced composite restoration.

Phase 2

Not yet recruiting

• Conditions: Healthy human volunteers satisfying ASA criteria I and II between age groups 16 - 45 years; Patients diagnosed with irreversible pulpitis in mandibular molars

• Registration Number: CTRI/2018/05/014019
• Lead Sponsor: Self

Brief Summary

This study is to compare the clinical performance of endodontically treated teethrestored with short-fiber reinforced composite and zirconia reinforcedcomposite resin as core material. A 100 patients diagnosed withirreversible pulpitis will be chosen according to inclusion and exclusioncriteria from the out-patient block, Department of Conservative Dentistry andEndodontics, SRM Dental College. And the patients divided into 2 groups, group1fiber reinforced composite and group 2 zirconia reinforced composite, A standardized endodontic procedureperformed using rotary instruments and the canals will be obturated usingstandardized GP points and AH Plus resin sealer. Following obturation, the pulp chamber will be cleared of sealer, guttapercha up to 1 mm apical into the root canal orifice, following which postendodontic restoration will be done based on the group. The post-endodontic restorations will be clinically evaluated immediatelyand in recall visit by two calibrated examiners, blinded to the materials usedand any disagreements during evaluation will be resolved by consensus among theexaminers. Modified US Public Health Service (USPHS) criteria will be usedby calibrators for recall evaluation for a period of 1,3, 6, 12 and 24months. Evaluation of the functional restorations willbe done in terms of marginal discoloration and adaptation, restorationintegrity, secondary caries and tooth/restoration fracture. The obtained datawill be tabulated and statistically analyzed.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-06
• Last Update Posted: 2020-11-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.Patients willing to actively participate in this in vivo study for periodic follow-ups will be selected.
• 2.Patients age from 16 to 45 years.
• 3.Patients with no wall defect (occlusal caries with intact proximal wall) and one wall defect either MO or DO (occlusal caries with involving proximal wall) diagnosed with irreversible pulpitis in mandibular first and second molars.
• 4.Mature teeth with closed apices.
• 5.Patients with class I occlusion with intact adjacent and opposing teeth.
• 6.Patients categorized under ASA (American Society of Anesthesiologists) 1 and 2.

Exclusion Criteria

• Patients categorized under ASA (American Society of Anesthesiologists) 3 and 4.
• 2.Poor oral hygiene with periodontal diseases and gingival index score more than 1.
• 3.Patients with non-vital teeth with periapical abscess 4.Patients with fractured teeth, obliterated canals, root resorption and retreatment cases.
• 5.Buccal and Lingual wall defect and wall thickness less than 2mm.
• 6.Presence of any para functional habits, wasting disease and maligned teeth.
• 7.Patients having TMJ problem.
• 8.Immature teeth with open apex.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To provide proper marginal adaptation, restoration integrity and prevent tooth fracture.	5 minutes

Secondary Outcome Measures

Name	Time	Method
It increases the longevity of the post endodontic restoration	2 years

Trial Locations

Locations (1)

SRM Dental College; 🇮🇳 Chennai, TAMIL NADU, India

SRM Dental College

🇮🇳Chennai, TAMIL NADU, India

Anand

Principal investigator

8344721473

anandsrmbds@gmail.com