Immediate Verses Delayed Surgical Periodontal Therapy After Endodontic Treatment in Endo Perio Lesion With Communication

NCT02630745 | Completed DMC

• 1 other identifier: Perio 2
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to conduct a prospective randomized clinical trial to evaluate the effect of immediate and delayed surgical periodontal therapy after non-surgical endodontic treatment on periodontal healing of the concurrent endodontic -periodontal lesion with communication.

Conditions

Attachment Loss; Tooth,Non Vital

Keywords

endodontic treatment; open flap debridement

Outcome Measures

Primary Outcomes (1)

• Relative Attachment Loss

  measurement done by periodontal probe with stents

  6 months in group 1, 9 months in group 2

Study Arms (2)

Immediate periodontal surgery (Group 1)

ACTIVE COMPARATOR

periodontal surgical procedure in the form of open flap debridement will be performed immediately( in which after debridement mucoperiosteal flaps will be repositioned and secured by using 3-0 non-absorbable black silk surgical suture) after obturation of the root canal system( using calcium hydroxide intracanal medicament placed with the help of 27 gauge endodontic syringe for 10 days and access cavity will be sealed with suitable sealer).

Procedure: Immediate periodontal surgery

Delayed periodontal surgery (Group 2)

ACTIVE COMPARATOR

periodontal surgical procedure in the form of open flap debridement( in which after debridement mucoperiosteal flaps will be repositioned and secured by using 3-0 non-absorbable black silk surgical suture) will be performed 3 months after obturation of the root canal system ( using calcium hydroxide intracanal medicament placed with the help of 27 gauge endodontic syringe for 10 days and access cavity will be sealed with suitable sealer).

Procedure: Delayed periodontal surgery

Interventions

Immediate periodontal surgery PROCEDURE

Treatment involves immediate surgical periodontal therapy in form of open flap debridement after non surgical endodontic treatment and obturation with gutta-percha and zinc oxide eugenol (ZOE) sealer. in concurrent endodontic periodontal lesions with communication .

Immediate periodontal surgery (Group 1)

Delayed periodontal surgery PROCEDURE

Treatment involves surgical periodontal therapy after 3 months of non surgical endodontic treatment and obturation with gutta-percha and zinc oxide eugenol (ZOE) sealer. in the form of open flap debridement in concurrent endodontic periodontal lesions with communication .

Delayed periodontal surgery (Group 2)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Wide base pocket, deep pocket depth
• Non vital tooth (confirmed by heat test, cold test and electronic pulp test)
• Radiographic periapical alveolar bone destruction with apical communication

You may not qualify if:

• Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
• Patients allergic to medication (local anaesthetic, antibiotics, NSAID).
• Pregnant or lactating mothers.
• Smokers and tobacco chewers.
• Grade 3 mobile teeth.
• Unrestorable tooth.
• Fractured/perforated roots.
• Developing permanent tooth.
• Previously root canal filled.
• History of recent periodontal treatment within 6 months prior to study.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Design

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

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 15, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 26, 2017

Record last verified: 2015-12