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Comparison of results of revascularization in immature non-vital permanent teeth using the calcium hydroxide and triple antibiotic paste as an medicament- A pilot study

Phase 4
Not yet recruiting
Conditions
Other specified disorders of teethand supporting structures,
Registration Number
CTRI/2022/06/043569
Lead Sponsor
Dr Morankar Rahul
Brief Summary

Revascularization is a regenerative treatmentmodality which has been advocated for management immature non-vital permanentteeth. It can lead to root development, thickening of dentinal walls andreestablishment of vitality. Root canal disinfection is a pre-requisite for anyregenerative endodontic procedure for which intracanal medicaments have beenfound very crucial role. Thus, this research is planned to assess the outcomes ofrevascularization in immature non-vital permanent teeth using the calciumhydroxide and triple antibiotic paste as an intracanal medicament. The Aim was to evaluate theoutcomes of revascularization in immature non-vital permanent teeth using thecalcium hydroxide and triple antibiotic paste as an intracanal medicament- Theobjective was to clinically and radiographicallyevaluate the outcomes of revascularization in immature non-vitalpermanent teeth using the calcium hydroxide and triple antibiotic paste as anintracanal medicament. This study will be carried out in the Division of Pedodontics andPreventive Dentistry, CDER, AIIMS, New Delhi. The Study duration was 2 yearsand sample size was T]total 20 teeth (10 in each group). The treatment plan andprognosis would be explained to the parents and a written informed consent willbe obtained. In the first visit, after access cavity will be prepared. Canalswould be irrigated followed by placement of intracanal medicament. Randomallocation would be done using computer-generated sealed envelope technique intotwo groups 1. Calcium hydroxide 2. Triple antibiotic paste. For the secondvisit, the patient will be recalled after 2 weeks to evaluate the clinicalsigns and symptoms. Intracanal medicament would be removed followed byinduction of bleeding into the root canal to allow the clot formation to occurfollowed placement of MTA over the blood clot and final restoration. Forfollow-up clinical evaluation- patient will be assessed for clinical signs andsymptoms at 3,6 and 12 months. Radiographic evaluation- Patient will beassessed for increase in root length and root width and resolution ofpreoperative radiolucency at 3, 6 and 12 months. Vitality assessment-Vitalitytesting will be done at 3, 6 and 12 months postoperatively.

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Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria
  • Participant’s age should be 14 years or less 2.
  • Immature non-vital permanent teeth as a result of trauma or dental caries 3.
  • Teeth should be in nollas stage 7, 8 or 9 of tooth development 4.
  • Consent for participation and willingness for the treatment.
Exclusion Criteria
  • Denied consent or not willing for participation 2.
  • Presence of any systemic/hematological disorder that can affects outcome of the procedure 3.
  • Patient is allergic to calcium hydroxide or triple antibiotic paste.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate the clinical success of revascularization procedure in immature non-vital permanent teeth using the calcium hydroxide and triple antibiotic paste as an intracanal medicament3, 6 and 12 months
Secondary Outcome Measures
NameTimeMethod
1.To evaluate the radiographic success of revascularization procedure in immature non-vital permanent teeth using the calcium hydroxide and triple antibiotic paste as an intracanal medicament2.To evaluate and compare the pulp vitality outcomes of revascularization using calcium hydroxide and triple antibiotic paste as an intracanal medicament

Trial Locations

Locations (1)

AIIMS NEW DELHI

🇮🇳

Delhi, DELHI, India

AIIMS NEW DELHI
🇮🇳Delhi, DELHI, India
Dr Morankar Rahul
Principal investigator
9855501651
drmorankarrahul@gmail.com

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