New treatment option for Periodontitis, Adult
Official title A Chitosan Brush and Enamel Matrix Derivative for Non-surgical Treatment of Furcations
ClinicalTrials.gov ID: NCT06684769
What this study is testing
- What it's testing
- Patients diagnosed with stage III or IV periodontitis who exhibit mandibular first or second molars with Class II, Subclass A, or B buccal and/or lingual mandibular furcation defects (horizontal probing depth of ≥ 3 mm ) will be recruited. Patients diagnosed with stage III or IV periodontitis who exhibit maxillary first or second molars with Class II, Subclass A, or B buccal furcation defects (horizontal probing depth of ≥ 3 mm ) if furcation involvement on the palatal side (mesiopalatal and distopalatal) does not exceed Class 1 will be recruited.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The patient is 18 years of age or older
- The patient does not have any systemic diseases that may affect the results of the study
- The patient has a plaque index of 20% or less at the study entry
- The patient has a history of severe localized or generalized periodontitis (stage III or IV)
- Completed the first and second steps of periodontal treatment (According to Treatment of stage I-III periodontitis-The EFP S3 level clinical practice...
You likely can't join if
- Patients who have systemic diseases that may affect the results of the study
- Use of medications that may affect study results (anti-osteoporotic drugs, statins, corticosteroids, anticoagulants)
- Patients who use calcium channel blockers, cyclosporine A or antiepileptic drugs if there are clinically visible hyperplastic changes in the gingival...
- Patients who have received any type of systemic antibiotics in the last six months prior to the start of the study and patients starting antibiotics...
- Patients requiring antibiotic premedication prior to periodontal treatment
- Oncological disease
See the full eligibility criteria
- The patient is 18 years of age or older
- The patient does not have any systemic diseases that may affect the results of the study
- The patient has a plaque index of 20% or less at the study entry
- The patient has a history of severe localized or generalized periodontitis (stage III or IV)
- Completed the first and second steps of periodontal treatment (According to Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline) (Sanz M. et al.)
- Buccal and/or lingual Class 2A and/or 2B furcation involvement (FI) defects on both sides of the Mandibular first and/or second molars after completing the first and second steps of periodontal treatment.
- Buccal Class 2A and/or 2B furcation involvement (FI) defects on both sides of the maxillary first and/or second molars after completion of the first and second step of periodontal treatment if furcation involvement on...
- Psychological appropriateness
- Consents to all follow-up visits
- Patients who have systemic diseases that may affect the results of the study
- Use of medications that may affect study results (anti-osteoporotic drugs, statins, corticosteroids, anticoagulants)
- Patients who use calcium channel blockers, cyclosporine A or antiepileptic drugs if there are clinically visible hyperplastic changes in the gingival margin.
- Patients who have received any type of systemic antibiotics in the last six months prior to the start of the study and patients starting antibiotics during the study
- Patients requiring antibiotic premedication prior to periodontal treatment
- Oncological disease
- Chemotherapy and/or radiotherapy (active or history)
- Pregnancy and breastfeeding
- Any condition or current treatment which, in the opinion of the investigator and/or consulting physician, may present an unreasonable risk
- Psychoemotional disorders and depression
- Use of antipsychotic medication or antidepressants
- Lack of patient motivation to undertake adequate dental care at home or complete periodontal treatment, patients residing outside Latvia
- Molars with combined endodontic-periodontal lesions, active endodontic infection
- Prosthetic factors for molars not allowing clinical measurements
- Huge restoration or amalgam fillings that could potentially cause fractures or furcation involvement
- Enamel pearls or filling or crown margins
- Decay or root resorption
- Tooth mobility degree 3
- Molars in which the gingival margin is positioned apically from the entrance into the furcation area
- Clinical attachment level and or pockets mesial and distal to the furcation involvement defect of 6 or more mm
- Strong vomiting reflex that would prevent adequate periodontal treatment
- People close to the study people, work colleagues, relatives, etc.
The study team makes the final eligibility decision.
Where it's taking place
- Riga, Latvia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Riga, Latvia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.