An Early Phase 1 interventional study of class II furcation defects management using propolis in Furcation Defects, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-14.
Sponsored by Cairo University · Early Phase 1, Interventional, and Treatment
Furcation involvement represents a challenge for treatment to many periodontists due to many factors including access, morphology, and variations of anatomical features of the furcation area. Furcation involvement treatment includes non-surgical periodontal therapy, resective surgery and regenerative surgery, regenerative therapy utilizing different graft materials and membranes is of high cost and research for new materials that can be cost-effective and available for all patients is continuing, propolis have been shown to be cost-effective therapy for bone and wound healing.
Propolis is a natural resinous product of the bee workers collected from trees to use it to stick their hives and form a coat to protect their hives from all sources of bacteria and invasions. Propolis is composed of more than 300 compounds, the most important of them are flavonoids like CAPE (caffeic acid phenyl ester). Propolis have shown anti-inflammatory, anti-oxidant, anti-bacterial, anti-fungal, anti-viral and more importantly regenerative effect and bone formation capabilities.
42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.
This study's planned enrollment of 10 is below the median of 27 across 38 interventional studies indexed under Furcation Defects.
Browse Furcation Defects studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Inclusion Criteria:
Inclusion criteria:
Exclusion Criteria:
Exclusion criteria:
Inclusion criteria: 1. Lower molars with class II furcation defects. 2. Full mouth plaque score (FMPS )\<20% at baseline. 3. Full mouth bleeding score (FMBS )\<10% at baseline. 4. Systemically healthy. 5. Cooperative patients. Exclusion criteria: 1. Smokers. 2. Pregnancy and lactation. 3. Stage 4 Grade C periodontitis.
Drug: class II furcation defects management using propolis
A full thickness flap will be elevated using muco-periosteal elevator to gain full access to the furcation defect. Then granulomatous tissue will be debrided from the osseous defect and the root surfaces will be carefully scaled and root planed by ultrasonic and hand instruments. The diagnosis of the class II furcation defect was then confirmed using a Naber's probe. Propolis preparation: Pure propolis will then be mixed with saline to give a proper mix/consistency and applied to completely fill the furcation defect.
Horizontal and Vertical Clinical Attachment Level (CAL)
Measured from the CEJ to the bottom of the gingival sulcus using Naber's periodontal probe. Measured from the CEJ to the bottom of the gingival sulcus using William's periodontal probe.
Time frame: 6 months
Radiographic Defect Fill
The depth of Furcation defect will be measured from the Furcation to the base of the defect at baseline and after six months to detect the amount of bone fill. Individually customized bite blocks will be created for the patients using alginate impression material and acrylic resin. Parallel-angle technique will be used to obtain standardized radiographs
Time frame: 6 months
Probing Depth (PD)
Measured from the gingival margin to the bottom of the gingival sulcus using William's periodontal probe with the probe inserted parallel to the long axis of the tooth
Time frame: 6 months
Bleeding on Probing (BOP)
BOP score will be assessed as the number of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized periodontal probe with a controlled (∼25 g) force to the bottom of the sulcus at six sites (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, disto-lingual) on all present teeth
Time frame: 6 months
Plaque Index (PI)
PI will be assessed using a standardized periodontal probe to agitate the gingival margin and assessing the presence or absence of plaque at the margin. This will be recorded at 4 sites per tooth on all teeth
Time frame: 6 months
Gingival Recession
Measured from the cementoenamel junction to the gingival margin using a William's graduated periodontal probe. The probe will be inserted into the sulcus gently parallel to the long axis of the tooth
Time frame: 6 months
Plan to share: No — one arm (10 participents) Inclusion criteria: Lower molars with class II furcation defects. Full mouth plaque score (FMPS )\<20% at baseline. Full mouth bleeding score (FMBS )\<10% at baseline. Systemically healthy. Cooperative patients. Exclusion criteria: Smokers. Pregnancy and lactation. Stage 4 Grade C periodontitis.
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