NCT03556163

Brief Summary

Aim of study was clinical comparative evaluation of using modified vertical internal mattress suturing technique and simple loop interrupted suturing technique in the outcome of modified Widman flap surgery for the management of chronic periodontitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

1.3 years

First QC Date

June 2, 2018

Last Update Submit

June 2, 2018

Conditions

Keywords

Chronic periodontitisModified Widman flap surgerySuturing technique

Outcome Measures

Primary Outcomes (1)

  • Clinical Attachment Level

    CAL was recorded from cementoenamel junction to base of pocket.

    6 months

Secondary Outcomes (1)

  • Bleeding on probing

    6 months

Study Arms (2)

Test Group

EXPERIMENTAL

Modified vertical internal mattress sutures + MWF surgery.

Procedure: Modified vertical internal mattress sutures + MWF surgery.

Control Group

ACTIVE COMPARATOR

Simple loop interrupted sutures + MWF surgery.

Procedure: Simple loop interrupted sutures + MWF surgery.

Interventions

Modified vertical internal mattress sutures were given after modified Widman flap surgery.

Test Group

Simple loop interrupted sutures were given after modified Widman flap surgery.

Control Group

Eligibility Criteria

Age30 Years - 52 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically healthy individual possessing ≥20 natural teeth.
  • Chronic periodontitis criteria as defined by division of Oral health at the centre for Disease Control and Prevention (CDC) in collaboration with American Academy of Periodontology (AAP) 42 (Page and Eke 2012) i.e.at least two or more interproximal sites with clinical attachment loss(CAL)≥4 mm (not on the same tooth),or ≥2 interproximal sites with probing pocket depth (PD)≥5 mm (not on the same
  • Residual pocket depth ≥4 mm after phase 1 therapy for surgical intervention.

You may not qualify if:

  • Patients with vertical bone loss.
  • Current or former smokers or use of tobacco in any form.
  • Patient on anti-inflammatory drugs or antibiotics or history of treatment with medication known to influence periodontal status or healing such as statins, glucocorticoids, phenytoin, calcium channel blockers, immunosuppressants, bisphosphonates or any other host modulatory drug within six months of commencement of study.
  • Pregnant women, lactating mothers and women taking oral contraceptives.
  • Patient who had undergone periodontal treatment within 6 months prior to the study.
  • Patient with average plaque index ≥1.5 after phase 1 therapy.
  • Miller Grade II /III tooth mobility after phase 1 treatment.
  • Periapical infection in any tooth of the surgical treatment segment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

PeriodontitisChronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Krishan Kumar, BDS

    POST GRADUATE INSTITUTE OF DENTAL SCIENCE,ROHTAK,HARYANA,INDIA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2018

First Posted

June 14, 2018

Study Start

December 1, 2016

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

June 14, 2018

Record last verified: 2018-06

Locations