Clinical and Radiographic Outcomes of Class II Furcation Defects Management Using Propolis: A Case Series

Furcation Defects Clinical Trial

Official title:

Clinical and Radiographic Outcomes of Class II Furcation Defects Management Using Propolis: A Case Series

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06060340
• Other study ID #: PERIO 3-3-2
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 15, 2023
• Est. completion date: October 15, 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Ahmed Said Allam, BDs
• Phone: 01093929125
• Email: ahmed.allam[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion 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:

• Exclusion criteria:

1. Smokers.

2. Pregnancy and lactation.

3. Stage 4 Grade C periodontitis.

Related Conditions & MeSH terms

• Furcation Defects

Intervention

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.

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo	El-Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months