Evaluation of Endodontic Status on Periodontal Healing of Concomitant Endodontic Periodontal Lesions

NCT02630173 | Completed DMC

• 1 other identifier: PGIDS/IEC/2014/111
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: To evaluate the effect of untreated endodontic infection on periodontal status in untreated non vital teeth with periapical radiolucency as compared to contralateral vital teeth. And also to evaluate the role of endodontic treatment on periodontal healing in successfully endodontically treated teeth with contralateral vital teeth. Methods: This study was performed in two parts. First part of this study was an observational cross sectional survey and second part was a clinical trial on patients selected from the survey.

Conditions

Periodontal Pocket

Keywords

endodontic treatment; scaling; root planning

Outcome Measures

Primary Outcomes (1)

• Improvement in periodontal parameters Probing depth

  periodontal parameters pocket depth (in mm) was measured at baseline to 6 months with the help of calibrated manual periodontal probe.

  baseline to 6months

Secondary Outcomes (4)

• plaque score

  baseline to 6 months

• bleeding on probing

  baseline to 6 months

• periapical score

  baseline to 6 months

• attachment loss

  baseline to 6 months

Study Arms (2)

Non vital teeth with apical radiolucency

EXPERIMENTAL

Endodontic treatment was performed in non vital teeth with periapical radiolucency. Local anesthesia was provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation was done.Using 3 % sodium hypochlorite, canal negotiation was done \& apical patency was achieved with #10 or #15K-files. Coronal flaring with # 2 and #3 Gates-Glidden drills was done.Calcium hydroxide was filled in the canals with the help of a lentulo spiral.At the second appointment,calcium hydroxide paste was removed and copious irrigation with 3% sodium hypochlorite was followed by 5.0 mL 17% ethylenediaminetetraacetic acid with a final rinse of 5.0 mL of 3% sodium hypochlorite. The canals were obturated with gutta-percha and ZOE sealer.

Procedure: Scaling and root planing; Other: Endodontic treatment

Vital teeth

ACTIVE COMPARATOR

Only scaling and root planing will be done in contralateral vital tooth with pocket depth \>5mm .Non surgical periodontal treatment in the form of scaling and root planing was provided in minimum of two sessions using ultrasonic scaler (Satelec P5 Booster Suprasson) and hand instruments (Hu-friedy scalers and curettes).

Procedure: Scaling and root planing

Interventions

Scaling and root planing PROCEDURE

Scaling and root planing was done in both the groups

Also known as: Non surgical Periodontal treatment

Non vital teeth with apical radiolucency; Vital teeth

Endodontic treatment OTHER

In non vital teethRoot canal treatment was completed in two visits. 3% Naocle was used as irritant and calcium hydroxide was used as intracanal medicament .Obturation was done with gutta percha.

Also known as: root canal treatment

Non vital teeth with apical radiolucency

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than or equal to18 years with more than 20 remaining teeth.
• Generalized chronic periodontitis was considered when ≥30% of sites were involved with clinical attachment loss (CAL) slight =1 or 2 mm, Moderate =3 or 4 mm, and Severe ≥5 mm41.
• Non vital tooth and contralateral vital tooth with PD ≥ 5 mm on at least one site.
• Non vital tooth confirmed by electric pulp test and cold test.
• Contralateral tooth with normal periapical conditions in the radiograph and with no evidence of root canal treatment and was vital as confirmed by electric pulp test and cold test.

You may not qualify if:

• Patients younger than 18 years
• Non vital tooth and contralateral vital tooth with mean PD\>8 and\<4.
• Endodontically treated teeth
• Smokers
• Unrestorable teeth
• Contralateral tooth having proximal carious lesions or was non vital.
• Inflammatory root resorption
• Fractured / Perforated roots
• Serious medical illness; Patients with uncontrolled or poorly controlled diabetes, unstable or life threatening conditions or requiring antibiotic prophylaxis (including infective endocarditis or prosthetic joint prophylaxis and immune compromising disorder)
• Pregnant mothers
• A history of recent periodontal therapy (with in previous 6 months)
• Teeth with established endodontic-periodontal lesion exhibiting less than 2 mm radiopaque bone between the periapical lesion and periodontal destruction, in which the periodontal probe reached the apex.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

MeSH Terms

Conditions

Periodontal Pocket

Interventions

Tooth Exfoliation; Root Planing; Endodontics

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor and Head

Study Record Dates

• First Submitted: December 6, 2015
• First Posted: December 15, 2015
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 16, 2015

Record last verified: 2015-12