NCT02861326

Brief Summary

Aim: The aim of this study was to evaluate the relationship between initial probing depth (IPD) and changes in clinical parameters following non-surgical periodontal treatment (NPT) in chronic periodontitis patients. Material and Methods: A total of 1672 periodontal pockets having 3 mm≤IPD≤9 mm in 15 chronic periodontitis patients were included. NPT consisting of oral hygiene instructions, scaling and root planing was applied in two sessions. Probing depth (PD), clinical attachment level, gingival recession (GR) were measured before and eight weeks after treatment. Pocket sites were grouped according to their IPD and root number of teeth as single- or multi-rooted.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

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

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

August 5, 2016

Last Update Submit

August 5, 2016

Conditions

Keywords

chronic periodontitis, dental scaling, periodontal pockets

Outcome Measures

Primary Outcomes (1)

  • Probing Depth

    Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.

    8 week

Secondary Outcomes (2)

  • Clinical attachment level

    8 week

  • Gingival recession

    8 week

Study Arms (1)

Patients

OTHER

Non-surgical periodontal treatment has performed to patients. Scaling and root planing were performed with Gracey curettes until the operator feels that root surface is clean, hard and smooth.

Device: Gracey Curettes

Interventions

Also known as: Hu-Friedy, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA
Patients

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Systemically healthy,
  • Non-smoker,
  • Chronic periodontitis diagnosed according to Armitage 1,
  • Aged between 35 and 65,
  • Not received any periodontal treatment within the last 3 months, • Have horizontal bone loss radiographically,
  • Presence at least 20 natural teeth except third molars
  • Consent to participate in the study.

You may not qualify if:

  • Any systemic disease that might interfere with the prognosis of periodontal disease (i.e. diabetes mellitus, HIV infection),
  • Smoking,
  • Antibiotics, anti-inflammatory drugs or any other medication taken within the previous 6 months that may affect the outcome of the study,
  • Any physical limitations or restrictions that might preclude normal oral hygiene procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic PeriodontitisPeriodontal Pocket

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 10, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Last Updated

August 10, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations