Root canal treatment in milk teeth using three root canal filling materials: A Double-blinded Randomized Controlled Trial.

Completed

Conditions: 1. Non vital teeth2. Teeth with deep carious lesion and exposures of pulp 3. Patients with the history of spontaneous pain4. Teeth showing adequate bone support and root length

Registration Number: CTRI/2011/06/001776

Lead Sponsor: Dr R Pramila

Brief Summary: Pulpectomy is indicated in teeth that show evidence of chronic inflammation or necrosis in the radicular pulp, with or without periapical or furcation pathology. However, endodontic treatment of primary teeth is more challenging than that of their permanent counterparts; this is because of their anatomical complexities of their root canal systems and their proximity to the developing permanent tooth, coupled with the difficulty in behavior management in children. Presently, the most commonly used materials are: Zinc-Oxide Eugenol, Iodoform based pastes, and calcium hydroxide. In 1967, it was shown that ZOE set in a dense mass which resisted resorption and was very irritating to the periapical tissues in rats. In 1979, it was speculated that the resorption rate of ZOE and the root differed, resulting in small areas of ZOE paste possibly being retained and because of its hardness it might deflect the path of eruption of the succedaneous tooth. It also has limited antibacterial action, and cause necrosis of bone and cementum. Dominguez et al, reported that combining Iodoform and Calcium Hydroxide, it gave a success rate of 100%. But the main disadvantage was intra-radicular resorption of the material. A mixture of Calcium Hydroxide, ZOE, and Iodoform [ENDOFLAS] gave a success rate of 83% with good healing, having the resorption limited to the excess extruded extraradicularly, without washing intra-radicularly and resorptive capabilities and was said to be a good alternative to the traditionally used materials. There have been only limited human studies on this subject. The present study aims to evaluate the clinical and radiographic efficiency of three root filling materials – ZOE with Iodoform [RC Fill], Calcium hydroxide with Iodoform [VITAPEX], ZOE and Calcium hydroxide with Iodoform [ENDOFLAS], for a period of 3,6 and 12 months. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 111

Inclusion Criteria

Non vital teeth 2.
Teeth with mild or moderate mobility [grade I and II] 3.
Teeth with deep carious lesion and exposures of pulp 4.
Patients with the history of spontaneous pain 5.
Teeth with no radiographically discernable internal or pathological external resorption 7.
Teeth with inter-radicular and peri-radicular radiolucencies.

Exclusion Criteria

Children with any medical history are excluded from the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
clinical evaluation: Pain, Redness, Swelling/Abscess, Draining fistula and Mobility.	Clinical and Radiographic evaluation of three root filling materials for a period of 3,6 and 12 months.
Radiographic evaluation: Furcation radiolucency, Periapical radiolucency, Internal/External root resorption, Deviated eruption of succedaneous teeth, Excessive filling material and its resorption.	Clinical and Radiographic evaluation of three root filling materials for a period of 3,6 and 12 months.

Secondary Outcome Measures

Name	Time	Method
No Secondary Outcome measures applicable for this study.	Not applicable

Trial Locations

Locations (1): saveetha dental college
🇮🇳
Chennai, TAMIL NADU, India
saveetha dental college
🇮🇳Chennai, TAMIL NADU, India
Dr R Pramila
Principal investigator
9003597232
dr.pramee@gmail.com