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

Primary Purpose

Class II Furcation Defects Management Using Propolis

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
class II furcation defects management using propolis
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Furcation Defects Management Using Propolis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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: Exclusion criteria: Smokers. Pregnancy and lactation. Stage 4 Grade C periodontitis.

Sites / Locations

  • Cairo university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

class II furcation defects

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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
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

Full Information

First Posted
September 23, 2023
Last Updated
September 23, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06060340
Brief Title
Clinical and Radiographic Outcomes of Class II Furcation Defects Management Using Propolis: A Case Series
Official Title
Clinical and Radiographic Outcomes of Class II Furcation Defects Management Using Propolis: A Case Series
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
October 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Furcation Defects Management Using Propolis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
class II furcation defects
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
class II furcation defects management using propolis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Horizontal and Vertical Clinical Attachment Level (CAL)
Description
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
Secondary Outcome Measure Information:
Title
Radiographic Defect Fill
Description
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
Title
Probing Depth (PD)
Description
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
Title
Bleeding on Probing (BOP)
Description
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
Title
Plaque Index (PI)
Description
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
Title
Gingival Recession
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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: Exclusion criteria: Smokers. Pregnancy and lactation. Stage 4 Grade C periodontitis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Said Allam, BDs
Phone
01093929125
Ext
+20
Email
ahmed.allam@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Manal Hosny, PHD
Phone
01118459362
Ext
+20
Email
manal.hosny@dentistry.cu.edu.eg
Facility Information:
Facility Name
Cairo university
City
Cairo
State/Province
El-Manial
ZIP/Postal Code
11555
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Said Allam, BDs
Phone
01093929125
Ext
+20
Email
ahmed.allam@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

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

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