Clinical trial NCT05643287: The Effect of Time on the Outcome of Periodontal Treatment.
Official title: The Effect of Time on the Outcome of Periodontal Treatment.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontitis
Keywords: Periodontitis
Re-evaluation
Non-surgical periodontal treatment
Lead sponsor: 251 Hellenic Air Force & VA General Hospital
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Probing Pocket Depth 0
timeFrame: Baseline
measure: Probing Pocket Depth 1
timeFrame: 6 weeks after periodontal treatment
measure: Probing Pocket Depth 2
timeFrame: 12 weeks after periodontal treatment
measure: Probing Pocket Depth 3
timeFrame: 24 weeks after periodontal treatment
Secondary outcomes:
measure: Clinical attachment level
timeFrame: Baseline, 6, 12, 24 weeks after treatment
measure: Plaque Index
timeFrame: Baseline, 6, 12, 24 weeks after treatment
measure: Bleeding on Probing
timeFrame: Baseline, 6, 12, 24 weeks after treatment
measure: Tooth Mobility
timeFrame: Baseline, 6, 12, 24 weeks after treatment
measure: Furcation involvement
timeFrame: Baseline, 6, 12, 24 weeks after treatment
measure: matrix metalloproteinase
timeFrame: Baseline, 6, 12, 24 weeks after treatment
measure: Oral Health Impact Profile (OHIP)-14 Questionnaire
timeFrame: Baseline, 6, 12, 24 weeks after treatment
Other outcomes:
Locations:
Study officials:
affiliation: 251 Hellenic Air Force & VA Hospital
name: George Koukos, DDS, PhD
role: STUDY_DIRECTOR
References: