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Impact of C-reactive Protein on Non Surgical Periodontal Treatment

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Non-surgical periodontal treatment
Sponsored by
University of Catania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: good condition of general health a minimum of 2 teeth for each quadrant with Pocket Depth (PD) ranging from 4-6 mm no involvement of the furcation a minimum of six teeth per quadrant, respectively Exclusion Criteria: periodontal therapy during the last 12 months assumption of antibiotics during the last 6 months pregnancy any systemic condition which might affect the effects of the study treatment previous or current radiation or immunosuppressive therapies use of mouthwash containing antimicrobials during the previous 3 months no use of hormonal contraceptives medication by anti-inflammatory and immunosuppressive drugs previous history of hard drinking smoking class II and III tooth mobility

Sites / Locations

  • AOU Policlinico G. Rodolico

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Periodontitis quadrant Scaling root planing (SRP)

MINST treatment

Arm Description

Each selected subject underwent quadrant SRP

Non surgical periodontal treatment performed with Minimally invasive non-surgical therapy (MINST) approach

Outcomes

Primary Outcome Measures

Reduction of Serum C-reactive protein changes
evaluation of serum c-reactive protein

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
August 18, 2023
Sponsor
University of Catania
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1. Study Identification

Unique Protocol Identification Number
NCT05836298
Brief Title
Impact of C-reactive Protein on Non Surgical Periodontal Treatment
Official Title
Impact of C-reactive Protein on Non Surgical Periodontal Treatment Performed With Mini-invasive Approach
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 2, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
May 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In light of the controversy that are already approved but that however still exists regarding the efficacy and influence the management of Periodontitis, the aim of this study was to evaluates, at 12-months follow-up, the post-treatment clinical and serum parameters in patients with periodontitis, treated by either Quadrant- Scaling and Root Planing (Q-SRP) treatment versus conventional Minimally invasive non-surgical therapy (MINST) treatment on serum C-reactive protein (CRP) and on Lipoprotein-associated phospholipase A2. Patients were also recalled for supportive periodontal treatment. The main objective was to analyze the effects of MINST or Q-SRP on clinical parameters and serum CRP and Lipoprotein-associated phospholipase A2 changes and if high CRP parameters at baseline influenced non surgical periodontal treatment.
Detailed Description
This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2016. The local ethical committee approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent. Subjects with a diagnosis of periodontitis were enrolled in this clinical trial. The inclusion criteria were: 1) good condition of general health, 2) a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm, 3) no involvement of the furcation, 4) a minimum of six teeth per quadrant, respectively. The exclusion criteria were: 1) periodontal therapy during the last 12 months, 2) assumption of antibiotics during the last 6 months, 3) pregnancy, 4) any systemic condition which might affect the effects of the study treatment, 5) previous or current radiation or immunosuppressive therapies, 5) use of mouthwash containing antimicrobials during the previous 3 months, 6) no use of hormonal contraceptives, 7) medication by anti-inflammatory and immunosuppressive drugs, 8) previous history of hard-drinking, 9) smoking, 10) class II and III tooth mobility. The primary outcome was the analysis of NSPT performed with either MINST or Q-SRP on periodontal parameters and tooth loss and on serum CRP expression changes between groups after 1- and also 8 years. Furthermore, The secondary objective was to examine the influence and interaction between NSPT protocol (MINST used as a reference) and the duration of treatment on serum CRP changes, as well as whether high baseline CRP levels influenced the efficacy of NSPT after 1-year follow-up. Variations for PD, CAL, FMBS, FMPS, PISA, Lp-PLA2 and CRP were collected and analyzed at 1, 3-, 6-month and at 1-year follow-up. Patients randomly undergo Q-SRP or MINST non surgical periodontal treatment performed in one session. All patients underwent an initial session with supragingival debridement. In addition, they received detailed information about the aetiology of periodontitis and individualized oral hygiene instructions, which included inter-dental plaque control and toothbrushing using a modified Bass technique. All participants were provided with the same type of toothbrush and toothpaste§ as well as interdental brushes‖. The NSPT was achieved by both hand and ultrasonic instrumentation using a No. 5/6/7 tip according to operator preference. In both groups, the ultrasonic device was used with constant water irrigation and with a 20 Hz of frequency at a 60 µn power setting. Patients in the Q-SRP group received quadrant scaling in four different sessions with an interval of 1 week between each quadrant treatment session. Each patient's first session started in the upper right maxillary quadrant. MINST was performed under local anaesthesia through careful subgingival debridement using ultrasonic scalers with specific thin tips# and Gracey micro-curettes** to minimize the trauma for the soft tissues. Under 3.5x magnification loupes, supra- and subgingival deposits were thoroughly debrided. After the operation, there was no subgingival rinsing to promote the establishment of a stable blood clot. No mouthwashes, antibiotics or other drugs were prescribed after treatment. At the end of each treatment session, patients were instructed and motivated to perform personal oral hygiene. Moreover, oral hygiene procedures were reinforced at 3 and 6 months after treatment. After the protocol, patients were enrolled in a maintenance program and recalled for clinical measurements at 1-, 3-, 6-months and 1-year follow-ups. For each patient, a custom-tailored SPT regimen was prescribed to avoid potential mechanical damage at the surgically treated region and enhance plaque reduction using a gentle roll technique for toothbrushing and interproximal cleaning devices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Quadrant Scaling and Root Planing (SRP) or MINST treatment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Sealed envelopes
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Periodontitis quadrant Scaling root planing (SRP)
Arm Type
Placebo Comparator
Arm Description
Each selected subject underwent quadrant SRP
Arm Title
MINST treatment
Arm Type
Active Comparator
Arm Description
Non surgical periodontal treatment performed with Minimally invasive non-surgical therapy (MINST) approach
Intervention Type
Other
Intervention Name(s)
Non-surgical periodontal treatment
Intervention Description
Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Quadrant Scaling and Root Planing (SRP) or MINST
Primary Outcome Measure Information:
Title
Reduction of Serum C-reactive protein changes
Description
evaluation of serum c-reactive protein
Time Frame
1-year follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: good condition of general health a minimum of 2 teeth for each quadrant with Pocket Depth (PD) ranging from 4-6 mm no involvement of the furcation a minimum of six teeth per quadrant, respectively Exclusion Criteria: periodontal therapy during the last 12 months assumption of antibiotics during the last 6 months pregnancy any systemic condition which might affect the effects of the study treatment previous or current radiation or immunosuppressive therapies use of mouthwash containing antimicrobials during the previous 3 months no use of hormonal contraceptives medication by anti-inflammatory and immunosuppressive drugs previous history of hard drinking smoking class II and III tooth mobility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola
Organizational Affiliation
Università degli Studi di Catania
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Policlinico G. Rodolico
City
Catania
ZIP/Postal Code
95124
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
Pubmed

Learn more about this trial

Impact of C-reactive Protein on Non Surgical Periodontal Treatment

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