The Effect of Time on the Outcome of Periodontal Treatment.

Periodontitis Clinical Trial

Official title:

The Effect of Time on the Outcome of Periodontal Treatment.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05643287
• Other study ID #: 251Hellenic
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: 251 Hellenic Air Force & VA General Hospital
• Contact: Georgia Malamoudi, DDS,MSc
• Phone: 6983394983
• Email: georgia.malamoudi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Periodontal treatment
Non-surgical periodontal treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
251 Hellenic Air Force & VA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing Pocket Depth 0	The distance between the gingival margin and the base of the sulcus/pocket	Baseline
Primary	Probing Pocket Depth 1	The distance between the gingival margin and the base of the sulcus/pocket	6 weeks after periodontal treatment
Primary	Probing Pocket Depth 2	The distance between the gingival margin and the base of the sulcus/pocket	12 weeks after periodontal treatment
Primary	Probing Pocket Depth 3	The distance between the gingival margin and the base of the sulcus/pocket	24 weeks after periodontal treatment
Secondary	Clinical attachment level	The distance between cementoenamel junction and the base of the sulcus/pocket	Baseline, 6, 12, 24 weeks after treatment
Secondary	Plaque Index	Number of sites with presence of dental plaque/ total number of sites	Baseline, 6, 12, 24 weeks after treatment
Secondary	Bleeding on Probing	Number of sites with presence of bleeding/total number of sites	Baseline, 6, 12, 24 weeks after treatment
Secondary	Tooth Mobility	degree of tooth mobility	Baseline, 6, 12, 24 weeks after treatment
Secondary	Furcation involvement	Presence or absence of furcation involvement and degree of furcation defect	Baseline, 6, 12, 24 weeks after treatment
Secondary	matrix metalloproteinase	matrix metalloproteinase 8 levels in whole saliva	Baseline, 6, 12, 24 weeks after treatment
Secondary	Oral Health Impact Profile (OHIP)-14 Questionnaire	Questionnaire	Baseline, 6, 12, 24 weeks after treatment