Riga Stradins University Institute of Stomatology
Riga, Latvia
Location status: Recruiting
Location contact
Anete Vaskevica, DDS
CONTACT
Anete Vaskevica, DDS
PRINCIPAL_INVESTIGATOR
Darta E Emulina, DDS
CONTACT
NCT Number: NCT06684769
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.
This study will be a prospective, randomized, single-blinded, controlled clinical trial with a split-mouth design.
Patients will be recruited from the clinics of the Riga Stradiņš University Institute of Stomatology of Riga, Latvia.
Before the baseline treatment, all patients who meet the inclusion criteria will be given detailed oral hygiene instructions and motivation.
Patients' furcation defects in each quadrant will be randomly allocated at a 1:1 ratio to either the application of Oscillating Chitosan Brush with Enamel Matrix Derivatives (test group) or Oscillating Chitosan Brush alone (control group).
Non-surgical periodontal treatment of furcation defects on the test side will be performed through the application of Oscillating Chitosan Brush with Enamel Matrix Derivatives and on the control side with Oscillating Chitosan Brush alone.
The re-evaluation of periodontal status will be performed 12 weeks following the baseline treatment.
Biofilm samples and gingival crevicular fluid (GCF) samples will be taken at the baseline and at 4 weeks.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Riga, Latvia
Location status: Recruiting
Anete Vaskevica, DDS
CONTACT
Anete Vaskevica, DDS
PRINCIPAL_INVESTIGATOR
Darta E Emulina, DDS
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Enamel Matrix Derivatives
Oscillating Chitosan Brush
Time frame: Baseline, 12 weeks
Pseudo marker of inflammation, lower scores mean a better outcome 0 = no bleeding;
Time frame: Baseline,12 weeks
Pseudo marker of inflammation, lower scores mean a better outcome.
Time frame: Baseline, 12 weeks
Marker of gain in attachment, lower scores mean a better outcome
Time frame: Baseline, 12 weeks
Marker of gain in attachment, Horizontal Furcation involvement measurement using Nabers Probe
Time frame: Baseline, 12 weeks
Marker of gain in attachment, Horizontal Furcation involvement measurement using UNC 15mm probe, lower scores mean a better outcome
Time frame: Baseline, 4 weeks,
Differences in the GCF of regeneration-related marker concentrations between test and control groups
Time frame: Baseline, 4 weeks,
Differences in the microbial profile between test and control groups
Time frame: Baseline
Evaluation of self-perceived pain using a 100 mm Visual analog scale (range 0 - 100) at baseline treatment visit; 0 - no pain, 100 - worst pain ever felt. Lower scores mean a better outcome.
Contact information is provided by the study sponsor or research team.
Anete Vaškevica, DDS
CONTACT
Dārta E Emuliņa, DDS
CONTACT
Riga Stradins University
Other
Non-surgical Treatment of Mandibular and Maxillary Molar Furcations With a Chitosan Brush With Adjunct Enamel Matrix Derivative- a Split-mouth Randomized Clinical Trial
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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