NCT02875470

Brief Summary

This study compares the efficacy of diamond burs and Gracey curettes in non-surgical periodontal treatment of chronic periodontitis by clinical, microbiological, biochemical parameters and scanning electron microscopic investigations on root surfaces. Two quadrants of each of the 12 patients were treated with diamond burs whereas other 2 quadrants were treated with Gracey curettes. Also 21 hopeless teeth received root planing either with diamond burs or curettes or no treatment at all and were then extracted for microscopic evaluations.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2013

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

October 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
Last Updated

August 23, 2016

Status Verified

August 1, 2016

Enrollment Period

10 months

First QC Date

August 9, 2016

Last Update Submit

August 17, 2016

Conditions

Keywords

non-surgical periodontal debridementroot planing/instrumentationcytokine(s)dental plaquemicroscopy, electron, scanning

Outcome Measures

Primary Outcomes (1)

  • Clinical tissue healing

    6 month

Secondary Outcomes (3)

  • Changing of the amount of pathogen microorganisms

    1 month

  • Changing of the gingival crevicular fluid biomarkers

    1 month

  • Root surface characteristic according to Scanning Electron Microscope

    6 month

Study Arms (2)

Intensiv Perio Set

EXPERIMENTAL

Root planing with diamond burs

Device: Intensiv Perio Set

Gracey curette

ACTIVE COMPARATOR

Root planing with Gracey curettes

Device: Gracey curette

Interventions

Diamond burs for root planing

Intensiv Perio Set
Gracey curette

Eligibility Criteria

Age37 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • clinical diagnosis of generalized chronic periodontitis (Armitage 1999)
  • presence of at least 3 teeth (1 molar, 2 non-molar teeth) with probing depth ≥ 5 mm in each quadrant

You may not qualify if:

  • presence of any known systemic disease or using medications that affect periodontal tissues
  • antibiotic treatment and/or periodontal treatment within the past 6 months
  • tobacco usage during the last 12 months
  • being pregnant or in the lactation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic PeriodontitisDental Plaque

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDental DepositsTooth Diseases

Study Officials

  • Eralp Buduneli, Proffessor

    Department of Periodontology, Faculty of Dentistry, Ege University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 23, 2016

Study Start

October 1, 2013

Primary Completion

August 1, 2014

Study Completion

April 1, 2015

Last Updated

August 23, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

De-identified individual data for all outcome measures will be made available within 3 years of study completion.