Furcation DefectsEarly Phase 1NCT06060340
Clinical and Radiographic Outcomes of Class II Furcation Defects Management Using Propolis: A Case Series
A Early Phase 1 study testing class II furcation defects management using propolis in people with Furcation Defects, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Furcation Defects
- What is being tested?
- class II furcation defects management using propolis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2023to 15 Oct 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Smokers.
- Pregnancy and lactation.
- Stage 4 Grade C periodontitis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Cairo, El-Manial, 11555
Ahmed Said Allam, BDs, 01093929125 ext. +20, ahmed.allam@dentistry.cu.edu.eg
About this study
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.
Read the 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.
- Conditions
- Furcation Defects
- Being tested
- class II furcation defects management using propolis
- Medical subject headings
- Furcation Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
class II furcation defects management using propolisDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| class II furcation defects | Experimental | 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. Receives: Drug: class II furcation defects management using propolis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start15 Oct 2023
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Furcation DefectsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Said Abd-El Azeem Allam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060340
- Sponsor's protocol ID
- PERIO 3-3-2
- Status last verified
- Feb 2024
- First submitted
- 23 Sep 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of Class II Furcation Defects Management Using Propolis: A Case Series
- ClinicalTrials.gov ID
- NCT06060340
- Acronym / sponsor ID
- PERIO 3-3-2
- Conditions
- Furcation Defects
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| class II furcation defects | Experimental | Drug: class II furcation defects management using propolisInclusion 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| class II furcation defects management using propolisA 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. | Drug | class II furcation defects |
Primary outcome
Horizontal and Vertical Clinical Attachment Level (CAL)
Time frame: 6 months
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.
5 secondary outcomes
Radiographic Defect Fill
Time frame: 6 months
Probing Depth (PD)
Time frame: 6 months
Bleeding on Probing (BOP)
Time frame: 6 months
Plaque Index (PI)
Time frame: 6 months
Gingival Recession
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No. 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.
Related trials for Furcation Defects
RecruitingPhase 3
Treatment of Class II Mandibular Furcation Defects
Class II Furcation Defect
Recruiting
Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Grade II Furcation Defects
Injectable Platelet-Rich Fibrin, Minimally Invasive
Recruiting
Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects
Class II Furcation Defect
Recruiting
Morphological Characteristics of Mandibular Molar Furcation Involvement and Efficacy of Regenerative Surgical Treatment
Periodontitis, Periodontitis (Stage 3)
Recruiting
Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements
Periodontitis, Furcation Defects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing class II furcation defects management using propolis in people with Furcation Defects, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Said Allam, BDs (01093929125 ext. +20, ahmed.allam@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal and Vertical Clinical Attachment Level (CAL) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.