PeriodontitisNCT05643287
The Effect of Time on the Outcome of Periodontal Treatment.
A study testing Periodontal treatment in people with Periodontitis, run by 251 Hellenic Air Force & VA General Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 3 Feb 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systematically healthy adults
- Informed consent form completion
- Periodontitis Diagnosis
- Patients not having received periodontal treatment since 12 months before
Who cannot join
- Medical History that interferes with wound healing
- Antibiotic and anti-inflammatory drugs intake
- Medication that induces gingival enlargement
- Pregnancy/ Lactation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- Periodontal treatment
- Keywords
- Periodontitis, Re-evaluation, Non-surgical periodontal treatment
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal treatmentProcedure or surgery
Non-surgical periodontal treatment
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis patients | Experimental | Periodontitis patients receiving non-surgical periodontal treatment. Receives: Procedure: Periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Depth 0
The distance between the gingival margin and the base of the sulcus/pocket
Measured: Baseline
Probing Pocket Depth 1
The distance between the gingival margin and the base of the sulcus/pocket
Measured: 6 weeks after periodontal treatment
Probing Pocket Depth 2
The distance between the gingival margin and the base of the sulcus/pocket
Measured: 12 weeks after periodontal treatment
Probing Pocket Depth 3
The distance between the gingival margin and the base of the sulcus/pocket
Measured: 24 weeks after periodontal treatment
Secondary outcomes (7)
Clinical attachment level
The distance between cementoenamel junction and the base of the sulcus/pocket
Measured: Baseline, 6, 12, 24 weeks after treatment
Plaque Index
Number of sites with presence of dental plaque/ total number of sites
Measured: Baseline, 6, 12, 24 weeks after treatment
Bleeding on Probing
Number of sites with presence of bleeding/total number of sites
Measured: Baseline, 6, 12, 24 weeks after treatment
Tooth Mobility
degree of tooth mobility
Measured: Baseline, 6, 12, 24 weeks after treatment
Furcation involvement
Presence or absence of furcation involvement and degree of furcation defect
Measured: Baseline, 6, 12, 24 weeks after treatment
matrix metalloproteinase
matrix metalloproteinase 8 levels in whole saliva
Measured: Baseline, 6, 12, 24 weeks after treatment
Oral Health Impact Profile (OHIP)-14 Questionnaire
Questionnaire
Measured: Baseline, 6, 12, 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start3 Feb 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 251 Hellenic Air Force & VA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgia Malamoudi, 251 Hellenic Air Force & VA General Hospital
- Investigators
- George Koukos, DDS, PhD, Study director, 251 Hellenic Air Force & VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643287
- Sponsor's protocol ID
- 251Hellenic
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2022
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Time on the Outcome of Periodontal Treatment.
- ClinicalTrials.gov ID
- NCT05643287
- Acronym / sponsor ID
- 251Hellenic
- Conditions
- Periodontitis
- Keywords
- Periodontitis, Re-evaluation, Non-surgical periodontal treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- 251 Hellenic Air Force & VA General HospitalUniversity, hospital or other
- Study start
- 3 Feb 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Periodontitis patients | Experimental | Procedure: Periodontal treatmentPeriodontitis patients receiving non-surgical periodontal treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Systematically healthy adults
- Informed consent form completion
- Periodontitis Diagnosis
- Patients not having received periodontal treatment since 12 months before
Key exclusion criteria (4 listed)
- Medical History that interferes with wound healing
- Antibiotic and anti-inflammatory drugs intake
- Medication that induces gingival enlargement
- Pregnancy/ Lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal treatmentNon-surgical periodontal treatment | Procedure or surgery | Periodontitis patients |
Primary outcome
Probing Pocket Depth 0
Time frame: Baseline
The distance between the gingival margin and the base of the sulcus/pocket
Probing Pocket Depth 1
Time frame: 6 weeks after periodontal treatment
The distance between the gingival margin and the base of the sulcus/pocket
Probing Pocket Depth 2
Time frame: 12 weeks after periodontal treatment
The distance between the gingival margin and the base of the sulcus/pocket
Probing Pocket Depth 3
Time frame: 24 weeks after periodontal treatment
The distance between the gingival margin and the base of the sulcus/pocket
7 secondary outcomes
Clinical attachment level
Time frame: Baseline, 6, 12, 24 weeks after treatment
Plaque Index
Time frame: Baseline, 6, 12, 24 weeks after treatment
Bleeding on Probing
Time frame: Baseline, 6, 12, 24 weeks after treatment
Tooth Mobility
Time frame: Baseline, 6, 12, 24 weeks after treatment
Furcation involvement
Time frame: Baseline, 6, 12, 24 weeks after treatment
matrix metalloproteinase
Time frame: Baseline, 6, 12, 24 weeks after treatment
Oral Health Impact Profile (OHIP)-14 Questionnaire
Time frame: Baseline, 6, 12, 24 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
George Koukos, DDS, PhD study director
251 Hellenic Air Force & VA Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal treatment in people with Periodontitis, run by 251 Hellenic Air Force & VA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgia Malamoudi, DDS,MSc (6983394983 ext. 0030, georgia.malamoudi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Pocket Depth 0 (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.