Evaluation of Three Irrigants, Sodium Hypochlorite, Chlorhexidine and Combination of CHX+H2O2 in Endodontic Treatment.

Periapical Periodontitis Clinical Trial

Official title:

Comparative Evaluation of Clinical and Radiographic Outcome by Using Three Different Irrigants, Sodium Hypochlorite (NaOCl), Chlorhexidine (CHX) and Combination of CHX+H2O2 in Primary Endodontic Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04373018
• Other study ID #: anshuyendo
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: April 2021

Study information

• Verified date: April 2020
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: Anshu Yadav
• Phone: 9050522830
• Email: anshuyadav99[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the synergistic effect of CHX + H2O2 when used as an irrigant during biomechanical preparation.in root canal treatment on periapical healing and compared with Chlorhexidine( CHX) and Sodium Hypochlorite (NaOCl).

Description:

After a thorough history, clinical and radiographic examination with all eligibility confirmation, written informed consent will be taken from the patient after explaining the procedure and its associated risks and benefits. Patients randomly allocated to one of the three study groups Sodium hypochlorite (NaOCl), Chlorhexidine (CHX) and combination of (CHX+H2O2). All three irrigants will be used according to standard protocol during biomechanical preparation. Pain analysis will be carried out preoperatively and postoperatively at every 6 hours for 1 day and then every 24 hours till 7 days after the intervention. All the subjects will be followed up for evaluation of clinical and radiographic success at 3, 6 months and 1year.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients over 18 years of age.

• Mature permanent mandibular molars.

• A radiographic evidence of periapical radiolucency (minimum size > 2mm×2mm) and a diagnosis of pulpal necrosis, as confirmed by the negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber.

Exclusion Criteria

• Diabetics, immunocompromised patients, pregnant females, any systemic disease.

• Patients with a history of analgesic intake within the past 3 days and antibiotics in the last month.

• Patients with pockets = 4mm or having marginal or furcal bone loss due to periodontitis.

• Non-restorable tooth, fractured, perforated roots and inflammatory root resorption.

• Teeth those are not suitable for rubber dam isolation.

• Primary teeth.

Related Conditions & MeSH terms

• Periapical Periodontitis
• Periodontitis

Intervention

Procedure:
• Sodium hypochlorite
Sodium hypochlorite irrigant will be used during biomechanical preparation.
• Chlorhexidine
Chlorhexidine irrigant will be used during biomechanical preparation.
• Chlorhexidine + Hydrogen peroxide
Chlorhexidine + Hydrogen peroxide irrigant will be used during biomechanical preparation.

Locations

Country	Name	City	State
India	PGIDS, Rohtak	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success	Absence of signs and symptoms Absence of tenderness to percussion Tooth mobility of grade 1 or less Absence of associated soft tissue swelling or tenderness to palpation Attachment loss of less than 5mm .; Two experienced observers with no knowledge of the treatment protocol will independently examine the immediate post obturation and follow up radiographs, mounted side by side, under controlled conditions. The treatment is considered successful only when both clinical and radiographic criteria are met. The worst outcome of an individual root decide the overall outcome for the tooth. In the event of disagreement, the two observers will meet to discuss their findings and came to an agreement.	Base line to 1 year.
Secondary	Radiographic success	Absence of periapical alterations (radiolucency at furcal or periapical region) Scoring of each tooth will be done according to the following five point scale (PAI); Score Description; Normal Periapical structure; Small changes in bone structure; Changes in bone structure with some mineral loss; Periodontitis with well defined radiolucent area; Severe periodontitis with exacerbating features	Baseline to 1 year
Secondary	Pain assessment	Assess the incidence and intensity of pain postoperatively at every 6 hours to 1 day till 7d ays using Visual Analogue scale.Pain intensity will be noted as no pain (0-4mm), mild pain (5-44), moderate pain (45-74mm) and severe pain (75-100mm) on the scale of 0-100mm	Baseline to 7 days