NCT03122977

Brief Summary

The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus full-mouth treatment (FM-SRP) in terms of acute-phase responses following no surgical periodontal treatment in obese patients affected by periodontitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 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

June 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

4 years

First QC Date

March 8, 2017

Last Update Submit

November 2, 2022

Conditions

Periodontal DiseasesObesity

Outcome Measures

Primary Outcomes (1)

  • Levels C-Reactive Protein

    Changes in C reactive protein (CRP). Unit of measure: mg/L

    Baseline, 24 hours and 3 months after treatment

Secondary Outcomes (15)

  • Full Mouth Plaque Score (FMPS)

    Baseline and 3 months after treatment

  • Full Mouth Bleeding Score (FMBS)

    Baseline and 3 months after treatment

  • Pocket probing depth (PPD)

    Baseline and 3 months after treatment

  • Clinical attachment level (CAL)

    Baseline and 3 months after treatment

  • Recession of the gingival margin (REC)

    Baseline and 3 months after treatment

  • +10 more secondary outcomes

Study Arms (2)

Full mouth scaling and root planing

EXPERIMENTAL

FM-SRP Non surgical periodontal treatment will be performed in all dentition within 24 hours

Procedure: FM-SRP

Quadrant scaling and root planing

ACTIVE COMPARATOR

Q-SRP Non surgical periodontal treatment will be performed in all dentition subdivided in four appointments. Each appointment will be performed in one week interval. In each appointment only a "quadrant" of the dentition will be instrumented.

Procedure: Q-SRP

Interventions

FM-SRPPROCEDURE

Supra- and sub-gingival mechanical instrumentation of the root surface of the whole dentition within 24 hours.

Also known as: Full mouth scaling and root planing
Full mouth scaling and root planing
Q-SRPPROCEDURE

Supra- and sub-gingival mechanical instrumentation of the root surface will be performed in all dentition subdivided in four appointments. Each appointment will be performed in one week interval. In each appointment only a "quadrant" of the dentition will be instrumented.

Also known as: Quadrant scaling and root planing
Quadrant scaling and root planing

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients affected by Periodontal Disease
  • % of periodontal pockets of the entire dentition
  • % bleeding on probing of the entire dentition
  • documented radiographic bone loss
  • diagnosis of Obesity as measured through Body Mass Index (BMI) superior than 30

You may not qualify if:

  • age younger than 18 years and older than 80 years
  • pregnant or lactating females
  • need of antibiotic coverage for periodontal treatment
  • treatment with statin and/or acetylsalicylic acid
  • BMI \> 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Pisa

Pisa, 56121, Italy

Location

MeSH Terms

Conditions

Periodontal DiseasesObesity

Interventions

Root Planing

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Filippo Graziani, DDS, PhD

    University of Pisa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Periodontology

Study Record Dates

First Submitted

March 8, 2017

First Posted

April 21, 2017

Study Start

June 1, 2016

Primary Completion

June 1, 2020

Study Completion

October 1, 2021

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations

IT(1)