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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06060340
Enrollment
10
Registered
2023-09-29
Start date
2023-10-15
Completion date
2024-10-15
Last updated
2024-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Furcation Defects

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.

Interventions

DRUGclass 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

*

Design outcomes

Primary

MeasureTime frameDescription
Horizontal and Vertical Clinical Attachment Level (CAL)6 monthsMeasured 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

MeasureTime frameDescription
Radiographic Defect Fill6 monthsThe 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)6 monthsMeasured 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)6 monthsBOP 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)6 monthsPI 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 Recession6 monthsMeasured 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

Countries

Egypt

Contacts

Primary ContactAhmed Said Allam, BDs
ahmed.allam@dentistry.cu.edu.eg01093929125
Backup ContactManal Hosny, PHD
manal.hosny@dentistry.cu.edu.eg01118459362

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026