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Completed

NCT Number: NCT02460926

Acute Phase Response & Periodontal Treatment

This study has compared quadrant scaling and root planing (Q-SRP) versus intensive treatment performed within 24 hours (FM-SRP) in terms of acute phase responses following treatment of periodontal disease. The primary aim was to compare the differences in CRP acute increase following FM-SRP versus Q-SRP therapy (24 hours after therapy). Secondary outcomes included changes in a broad array of inflammatory and endothelial injury markers between groups. Patients were randomly assigned to either FM-SRP and Q-SRP. Data indicated that non-surgical periodontal therapy performed within 24 hours induced greater perturbations of systemic inflammation compared to conventional treatment.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Aim. A moderate acute-phase response occurs 24 hours following full-mouth non-surgical treatment (FM-SRP). Aim of this study will be to compare quadrant scaling (Q-SRP) versus FM-SRP in terms of systemic acute (24 hours) and medium-term (3 months) inflammation.

Material & Methods. 38 periodontitis-affected subjects will be randomly allocated to FM-SRP or Q-SRP after a baseline visit. Periodontal and anthropometric parameters, such as systolic and diastolic bood pressure, BMI and temperature, will be collected at baseline and 3 months. Serum samples will be drawn at baseline, 1, 7 and 90 days after treatment. High sensitivity assays for a broad array of inflammatory (PCR, IL-6, TNF-alpha) and endothelial assays will be performed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients presenting with probing pocket depths (PPD) ≥5 mm,
  • bleeding on probing on at least 25% of their total sites
  • documented radiographic alveolar bone loss

Exclusion criteria

  • age earlier than 18 and older than 70 years;
  • pregnant or lactating females;
  • females using contraceptive methods;
  • reported diagnosis of any systemic illnesses including cardiovascular, renal and liver diseases;
  • any pharmacological treatment within the 3 months before the beginning of the study;
  • PT in the previous 6 months.

Treatment and study plan

Scaling & Root Planing

Procedure

It consists in the non-surgical debridement of the sub gingival area affected by periodontal disease

Other names: SRP

Primary outcomes

  1. C reactive Protein

    Time frame: 24 Hours

Secondary outcomes

  1. C reactive Protein

    Time frame: 7 days, 90 days

  2. Tumor Necrosis Factor - alpha

    Time frame: 24 Hours, 7 days, 90 days

  3. Interleukin - 6

    Time frame: 24 Hours, 7 days, 90 days

  4. periodontal pocket depth (PPD)

    Time frame: 90 days

    mean in mm

  5. periodontal pocket depth (PPD)

    Time frame: 90 days

    mean in site > 4mm

  6. clinical attachment level (CAL)

    Time frame: 90 days

    mean in mm

  7. number of pockets > 4 mm

    Time frame: 90 days

    number of pockets > 4 mm

  8. Full Mouth Plaque Score

    Time frame: 90 days

    presence/absence of dental plaque in percentual values

  9. Full Mouth Bleeding Score

    Time frame: 90 days

    presence/absence of sites bleeding on probing in percentual values

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Collaborators

  • Eastman Dental Insitute and Hospital

Registry information

Official study title

Acute Phase Response Following Full Mouth Versus Quadrant Non-Surgical Periodontal Treatment. A Randomized Clinical Trial

Acronym: PERIOSYST-1

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 3, 2015
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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