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NCT Number: NCT05643287

The Effect of Time on the Outcome of Periodontal Treatment.

Re-evaluation after non-surgical periodontal treatment remains an integral part of comprehensive periodontal therapy. This re-evaluation determines if a patient is in need either of surgical periodontal therapy or a personalized program of supportive periodontal treatment. However important, this time point is yet to be determined.This interventional study aims to clarify which is the best time to re-evaluate the therapeutic result after non-surgical periodontal treatment.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This randomized clinical trial aims to clarify which is the best time to re-evaluate the therapeutic result after non-surgical periodontal treatment. For this purpose the participants will be recruited among people who come to the Periodontal Department of 251 Hellenic Air Force Hospital for periodontal treatment. Each participant is going to submit informed consent in order to be included in the study. Patients with the diagnosis of Periodontitis will be submitted to non-surgical periodontal treatment with ultrasonic and manual scalers within two sessions, under local anaesthesia. The result of the treatment is going to be evaluated at 6, 12 and 24 weeks after treatment completion.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Systematically healthy adults
  • Informed consent form completion
  • Periodontitis Diagnosis
  • Patients not having received periodontal treatment since 12 months before

Exclusion criteria

  • Medical History that interferes with wound healing
  • Antibiotic and anti-inflammatory drugs intake
  • Medication that induces gingival enlargement
  • Pregnancy/ Lactation

Treatment and study plan

Periodontal Treatment

Procedure

Non-surgical periodontal treatment

Primary outcomes

  1. Probing Pocket Depth 0

    Time frame: Baseline

    The distance between the gingival margin and the base of the sulcus/pocket

  2. Probing Pocket Depth 1

    Time frame: 6 weeks after periodontal treatment

    The distance between the gingival margin and the base of the sulcus/pocket

  3. Probing Pocket Depth 2

    Time frame: 12 weeks after periodontal treatment

    The distance between the gingival margin and the base of the sulcus/pocket

  4. Probing Pocket Depth 3

    Time frame: 24 weeks after periodontal treatment

    The distance between the gingival margin and the base of the sulcus/pocket

Secondary outcomes

  1. Clinical attachment level

    Time frame: Baseline, 6, 12, 24 weeks after treatment

    The distance between cementoenamel junction and the base of the sulcus/pocket

  2. Plaque Index

    Time frame: Baseline, 6, 12, 24 weeks after treatment

    Number of sites with presence of dental plaque/ total number of sites

  3. Bleeding on Probing

    Time frame: Baseline, 6, 12, 24 weeks after treatment

    Number of sites with presence of bleeding/total number of sites

  4. Tooth Mobility

    Time frame: Baseline, 6, 12, 24 weeks after treatment

    degree of tooth mobility

  5. Furcation involvement

    Time frame: Baseline, 6, 12, 24 weeks after treatment

    Presence or absence of furcation involvement and degree of furcation defect

  6. matrix metalloproteinase

    Time frame: Baseline, 6, 12, 24 weeks after treatment

    matrix metalloproteinase 8 levels in whole saliva

  7. Oral Health Impact Profile (OHIP)-14 Questionnaire

    Time frame: Baseline, 6, 12, 24 weeks after treatment

    Questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

George Koukos, DDS,PhD

CONTACT

[email protected]

6983520282 ext. 0030

Georgia Malamoudi, DDS,MSc

CONTACT

[email protected]

6983394983 ext. 0030

Sponsors and collaborators

Lead sponsor

251 Hellenic Air Force & VA General Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2022
Registry last updated
Dec 18, 2024

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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