Impact of C-reactive Protein on Non Surgical Periodontal Treatment

NCT05836298 | Completed DMC

• 1 other identifier: 149-22-PO
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Reduction of Serum C-reactive protein changes

  evaluation of serum c-reactive protein

  1-year follow up

Study Arms (2)

Periodontitis quadrant Scaling root planing (SRP)

PLACEBO COMPARATOR

Each selected subject underwent quadrant SRP

Other: Non-surgical periodontal treatment

MINST treatment

ACTIVE COMPARATOR

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

Other: Non-surgical periodontal treatment

Interventions

Non-surgical periodontal treatment OTHER

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

MINST treatment; Periodontitis quadrant Scaling root planing (SRP)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

AOU Policlinico G. Rodolico

Catania, 95124, Italy

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Gaetano Isola

  Università degli Studi di Catania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 1, 2023
• Study Start: January 2, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year
• Access Criteria: Pubmed

Locations

IT (1)