Regenerative Endodontics in Mature Necrotic Teeth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorSuez Canal University
About this trial
The goal of this clinical trial is to learn if nanochitosan can achieve regeneration in mature necrotic teeth. It will also provide data about the healing potential \& postoperative pain after using different irrigation protocols. The main question it aims to answer are:
Does nanochitosan can demonstrate clinically successful outcome, minimize postoperative pain \& flare ups? What is the regenerative potential of mature necrotic teeth with chronic apical periodontitis? Is regeneration an alternative treatment modality for mature necrotic teeth with apical periodontitis? Researcher will compare the regenerative potential \& postoperative pain after using 2.5% NaOCl+ 17% EDTA, 1% nanochitosan \& 1% nanochitosan+17% EDTA to see if 1% nanochitosan alone or when used with 17% EDTA can enhance regeneration.
Participants' root canals will be:
Divided into 3 groups \&irrigated thoroughly by the different irrigation protocols (2.5% NaOCl+ 17% EDTA, 1% nanochitosan \& 1% nanochitosan+ 17% EDTA) Regenerative procedures will be done Clinical sensibility test \& radiographic changes will be evaluated at 6\&12 months follow up periods Detection of inflammatory mediators from GCF at 6 months follow up periods to be compared with its preoperative levels as a predictor for success or failure Assessment of postoperative pain using Numerical Rating Scale at 6, 12, 24 hours then daily for 7 days
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with good general health, without known systemic diseases or allergic reactions to any of the material used affecting healing outcome, with no sex predilection
Disqualifiers
medically compromised patients, systemic conditions e.g. uncontrolled diabetes or those on immunosuppressive drugs.
pregnant females
patients with generalized chronic periodontitis, mobility, and deep pockets
non-restorable teeth or teeth with open apices
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention 1: 1% nanochitosan
Procedure/SurgeryIrrigation with 1% nanochitosan
Intervention 2: 1% nanochitosan & 17% EDTA
Procedure/SurgeryIrrigation with 1% nanochitosan \& 17% EDTA
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Intervention 1: 1% NanochitosanActive comparator 1 intervention
Group C: Intervention 2: 1% Nanochitosan & 17% EDTAActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Assessment of clinical success & healing of single visit regenerative endodontics in mature necrotic teeth with chronic apical periodontitis.
Clinical success will be evaluated via: 1. Sensibility tests using cold test (Endo Ice) \& electric pulp tester at 6 \& 12 months follow up periods. 2. Detection of molecular markers (inflammatory mediators) from the gingival crevicular fluid at 6 months follow up periods using ELISA. 3. Radiographic analysis of the changes in size of periapical lesion using Cone Beam Computed Tomography (CBCT) at 6 \& 12 months follow up periods.
Time frame
1 year follow upSecondary outcomes
1
Postoperative pain assessment after single visit regenerative endodontics in mature necrotic teeth with chronic apical periodontitis.
Postoperative pain will be assessed using Numerical Rating Scale by reporting pain levels at 6, 12, 24 hours, then daily for 7 days and comparing it with pain levels prior to the procedures.
Time frame
1 year follow upSponsors and contacts
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Source ClinicalTrials.gov
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