Comparison of Healing of Apical Periodontitis in Periodontally Diseased and Healthy Patients.

NCT03711942 | Completed DMC

• 1 other identifier: Gaurav Endo
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Periodontal health may jeopardize the success of endodontic treatment.Intraorifice barrier apart from enhancing probability of success of endodontic treatment may also augment periodontal therapy as intra pulpal infection is known to contribute in worsening of periodontal health by promoting marginal bone loss and pocket formation.This study compared the apical healing in healthy and periodontally compromised teeth and evaluated the effect of intra orifice barrier and base in the healing of apical periodontitis.

Conditions

Apical Periodontitis

Keywords

Root canal treatment, intraorifice barrier.

Outcome Measures

Primary Outcomes (1)

• Healing of apical periodontitis

  Clinical success as depicted by absence of signs and symptoms, and radiographic success demonstrated by absence of periapical alterations (radiolucency at furcal or periapical region).

  Baseline to one year

Secondary Outcomes (1)

• Healing of marginal periodontitis

  Baseline to one year

Study Arms (6)

Periodontally Healthy IOB

ACTIVE COMPARATOR

Intra orifice barrier (IOB) was placed in periodontally healthy molar.

Procedure: Intra orifice barrier

Periodontally Healthy Base

EXPERIMENTAL

2mm thick base was applied in periodontally health teeth.

Procedure: Base

Periodontally healthy control

EXPERIMENTAL

coronal access was restored with composite resin without any base.

Procedure: Control

Periodontally diseased IOB

ACTIVE COMPARATOR

Intra orifice barrier (IOB) was placed in periodontally healthy molar

Procedure: Intra orifice barrier

Periodontally diseased Base

ACTIVE COMPARATOR

2mm thick Base of GIC was applied under composite restoration

Procedure: Base

Periodontally diseased control

ACTIVE COMPARATOR

coronal access was restored with composite resin without any base

Procedure: Control

Interventions

Intra orifice barrier PROCEDURE

After primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.3mm GP in the orifice was removed and intraorifice barrier and 2mm thick base was given of GIC.

Periodontally Healthy IOB; Periodontally diseased IOB

Base PROCEDURE

After primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.2mm thick Base of GIC was applied over the orifice before composite restoration

Periodontally Healthy Base; Periodontally diseased Base

Control PROCEDURE

After primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.coronal accees upto orifice was restored with composite resin

Periodontally diseased control; Periodontally healthy control

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Permanent mandibular molar with pulpal necrosis as confirmed by negative response to pulp sensibility test (cold and electric pulp test),
• Radiographic evidence of apical periodontitis in the form of periapical radiolucency (minimum size ≥ 2 mm \~ 2 mm),
• Probing Depth of not more than 5mm.

You may not qualify if:

• Patient with diabetes,
• History of antibiotic intake in past 1 month,
• Presence of any immunocompromised conditions,
• Pregnant women, and
• Root filled and unrestorable teeth

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Alkalies

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 19, 2018
• Study Start: October 15, 2016
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: October 19, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share