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

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.

Study Overview

• Status: Recruiting
• Conditions: Furcation Defects
• Intervention / Treatment: Drug: class II furcation defects management using propolis

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Ahmed Said Allam, BDs; Phone Number: +20 01093929125; Email: ahmed.allam@dentistry.cu.edu.eg
• Study Contact Backup: Name: Manal Hosny, PHD; Phone Number: +20 01118459362; Email: manal.hosny@dentistry.cu.edu.eg

Study Locations

• Egypt
  • El-Manial
    • Cairo, El-Manial, Egypt, 11555
      • Recruiting
      • Cairo University
      • Contact: Ahmed Said Allam, BDs; Phone Number: +20 01093929125; Email: ahmed.allam@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: class II furcation defects; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): October 15, 2024

Study Registration Dates

• First Submitted: September 23, 2023
• First Submitted That Met QC Criteria: September 23, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Furcation Defects; Anti-Infective Agents; Propolis
• Other Study ID Numbers: PERIO 3-3-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

one arm (10 participents)

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 and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No