Glycemic Levels on Healing of Periapical Lesions in Type 2 Diabetic Patients

NCT04355988 | Completed DMC

• 1 other identifier: Brhadyumna Bharath PGIDS
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Increased incidence of peri-radicular lesions have been reported in diabetic patients which has been implicated due to compromised immune response. Much research has been done on the pathogenesis and progression of this lesion in diabetic patients. Although there are few studies which focus on healing of periradicular lesions after nonsurgical root canal treatment. There is a lacunae in literature which highlights peri-radicular healing after nonsurgical root canal treatment in relation to Glycaemic control in diabetic patients measured in terms of HbA1c levels.

Conditions

Periapical Lesions

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to one year

Secondary Outcomes (1)

• Radiographic success

  Baseline to one year

Study Arms (3)

Well controlled diabetics

ACTIVE COMPARATOR

Nonsurgical root canal treatment

Procedure: Nonsurgical root canal therapy

Poorly controlled diabetics

ACTIVE COMPARATOR

Nonsurgical root canal treatment

Procedure: Nonsurgical root canal therapy

Healthy control group

ACTIVE COMPARATOR

Nonsurgical root canal treatment

Procedure: Nonsurgical root canal therapy

Interventions

Nonsurgical root canal therapy PROCEDURE

After administration of LA and rubber dam isolation, acess cavity will be prepared using carbide burs in high speed hand piece with copious irrigation. Working length will be determined using root ZX apex locator and will be verified radiographically. Canal preparation will be done with protaper rotary instruments in which Sx to S2 will be used to shape the canals and F1 and F2 will be used to finish until the apex. 5ml of 5.25% NaOCl will be used as irrigant after each instrument. After instrumentation , the canals will be irrigated with 5.0 ml of 17% EDTA for 1minute followed by irrigation with 5.0 ml of 5.25% NaOCl. Canals will be dried with absorbent paper points, filled with calcium hydroxide paste and access cavity will be restored with IRM. Patients will be recalled after 1 week.At the next appointment, after paste removal, copious irrigation with 5.25% NaOCl will be done and canals will be dried with paper points. Canals will be obturated with Gutta-Percha and ZOE based sealer.

Also known as: Root canal treatment

Healthy control group; Poorly controlled diabetics; Well controlled diabetics

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Known patients of diabetes mellitus type 2 with HbA1c \> 6.5%
• Mature permanent mandibular posterior tooth having apical periodontitis
• requiring primary root canal treatment
• Age between 30 - 65 years.
• A radiographic evidence of periapical radiolucency (minimum size ≥ 2mm×2mm) and a diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber.

You may not qualify if:

• Patient having advanced periodontal disease
• Patient having systemic disorders other than diabetes
• Pregnancy
• Procedural errors
• History of antibiotic intake in past one month

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: April 21, 2020
• Study Start: April 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: January 1, 2020
• Last Updated: April 21, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)