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Impact of Periodontal Treatment on Growth Differentiation Factor-15 Levels

Impact of Non Surgical Periodontal Treatment on Growth Differentiation Factor-15 Levels

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05720481
Enrollment
46
Registered
2023-02-09
Start date
2019-09-20
Completion date
2022-10-15
Last updated
2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases

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 6-months follow-up, the post-treatment clinical and serum parameters in patients with periodontitis, treated by either Full Mouth Scaling and Root Planing (FM-SRP) treatment versus conventional oral hygiene treatment on serum CRP and Growth differentiation factor-15 levels.

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. Patients randomly undergo to full mouth SRP or Quadrant SRP

Interventions

patients were treated with full mouth Scaling and root planing

OTHERQuadrant Scaling and root planing

patients were treated with quadrant Scaling and root planing

Sponsors

University of Catania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Sealed envelopes

Intervention 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 Full-Mouth Scaling and Root Planing

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes

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 a 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

Design outcomes

Primary

MeasureTime frameDescription
reduction of Growth differentiation factor-15 serum levels6 monthsevaluation of serum Growth differentiation factor-15 change

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026