Intrabony Periodontal DefectNCT06530199
Simplified Papilla Preservation Flap(SPPF) and Enamel Matrix Derivative(EMD) With or Without Connective Tissue(CTG) Wall for the Treatment of Non Contained Infrabony Defects. A Randomized Controlled Clinical Trail
A study testing Enamel matrix derivative in people with Intrabony Periodontal Defect, run by Krishnadevaraya College of Dental Sciences & Hospital.
Trial summary
Research is to compare and evaluate the clinical and radiographic outcomes of the enamel matrix derivative with or without connective tissue wall graft for noncontained infrabony defects using simplified papilla preservation technique . Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- Enamel matrix derivative
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jul 2025
- Phase
- Interventional
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients willing to participate in the study.
- Participants aged ≥18 years to 55 years.
- Presented with non contained infra bony defects.
- Presence of at least 1 non contained infra bony defect(IBD) with a pocket probing depth ≥6mm after reevaluation of the hygienic phase and a depth of IBD ≥3mm as detected on radiographs, with radiographic angulation of ≥37⸰ , and exhibiting a 1 or 2 wall infra bony defect15(assessed by a bone sounding and confirmed intrasurgically)
- Patient's full mouth plaque score and bleeding score <20% at the time of surgical procedure.
- No history of periodontal surgery at the experimental site.
Who cannot join
- Grade III mobility, endodontically treated teeth.
- Pregnant and lactating females.
- History of tobacco smoking .
- Patients with systemic disease.
- Known allergy or hypersensitivity to EMD.
- Presence of pulpal and peri apical involvement
Trial locations and contacts
No sites are listed yet.
Head of the department and professor contact
About this study
Research is to compare and evaluate the clinical and radiographic outcomes of the enamel matrix derivative with or without connective tissue wall graft for noncontained infrabony defects using simplified papilla preservation technique .
Read the detailed description
Research is to compare and evaluate the clinical and radiographic outcomes of the enamel matrix derivative with or without connective tissue wall graft for noncontained infrabony defects using simplified papilla preservation technique .The objectives is to assess the probing pocket depth reduction, clinical attachment level gain,gingival recession depth and radiographic bone gain. The TEST group will be treated withSIMPLIFIED PAPILLA PRESERVATION flap with connective tissue graft and enamel matrix derivative and the CONTROL group will be treated with SIMPLIFIED APILLA PRESERVATION flap and enamel matrix derivative. The total number of participants included will be 30 (Control-15; Study-15) with a 6 month follow up.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- Enamel matrix derivative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enamel matrix derivativeProcedure or surgery
Also called Connective tissue graft technique
connective tissue graft and Enamel matrix derivative in the defect area
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Simplified papilla preservation flap with enamel matrix derivative will be performed Receives: Procedure: Enamel matrix derivative |
| Test group | Experimental | Simplified papilla preservation flap with connective tissue graft and enamel matrix derivative will be performed Receives: Procedure: Enamel matrix derivative |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical attachment gain
change in attachment level for patient with isolated 2 or 3 wall defect treated with enamel matrix derivative and connective tissue wall graft in 1,3 and 6 months follow up
Measured: 6 months
Secondary outcomes (5)
pocket probing depth
change in pocket probing depth from baseline to 1,3 and 6 months
Measured: 6 months
radiographic bone gain
change in radiographic bone level from baseline to 1,3,6 months
Measured: 6 months
recession reduction
change in recession from baseline to 1,3 and 6 months
Measured: 6 months
plaque index
change in plaque index from baseline to 1,3 and 6 months
Measured: 6 months
gingival index
change in calculus index from baseline to 1,3 and 6 months
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 posted31 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrabony Periodontal DefectStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530199
- Sponsor's protocol ID
- 02_D012_147502
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplified Papilla Preservation Flap(SPPF) and Enamel Matrix Derivative(EMD) With or Without Connective Tissue(CTG) Wall for the Treatment of Non Contained Infrabony Defects. A Randomized Controlled Clinical Trail
- ClinicalTrials.gov ID
- NCT06530199
- Acronym / sponsor ID
- 02_D012_147502
- Conditions
- Intrabony Periodontal Defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 31 Jul 2024 (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.
Research is to compare and evaluate the clinical and radiographic outcomes of the enamel matrix derivative with or without connective tissue wall graft for noncontained infrabony defects using simplified papilla preservation technique .
Detailed description
Research is to compare and evaluate the clinical and radiographic outcomes of the enamel matrix derivative with or without connective tissue wall graft for noncontained infrabony defects using simplified papilla preservation technique .The objectives is to assess the probing pocket depth reduction, clinical attachment level gain,gingival recession depth and radiographic bone gain. The TEST group will be treated withSIMPLIFIED PAPILLA PRESERVATION flap with connective tissue graft and enamel matrix derivative and the CONTROL group will be treated with SIMPLIFIED APILLA PRESERVATION flap and enamel matrix derivative. The total number of participants included will be 30 (Control-15; Study-15) with a 6 month follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: Enamel matrix derivativeSimplified papilla preservation flap with enamel matrix derivative will be performed |
| Test group | Experimental | Procedure: Enamel matrix derivativeSimplified papilla preservation flap with connective tissue graft and enamel matrix derivative will be performed |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients willing to participate in the study.
- Participants aged ≥18 years to 55 years.
- Presented with non contained infra bony defects.
- Presence of at least 1 non contained infra bony defect(IBD) with a pocket probing depth ≥6mm after reevaluation of the hygienic phase and a depth of IBD ≥3mm as detected on radiographs, with radiographic angulation of ≥37⸰ , and exhibiting a 1 or 2 wall infra bony defect15(assessed by a bone sounding and confirmed intrasurgically)
- Patient's full mouth plaque score and bleeding score <20% at the time of surgical procedure.
Key exclusion criteria (6 listed)
- Grade III mobility, endodontically treated teeth.
- Pregnant and lactating females.
- History of tobacco smoking .
- Patients with systemic disease.
- Known allergy or hypersensitivity to EMD.
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 |
|---|---|---|
| Enamel matrix derivativeAlso: Connective tissue graft techniqueconnective tissue graft and Enamel matrix derivative in the defect area | Procedure or surgery | Test group, control group |
Primary outcome
clinical attachment gain
Time frame: 6 months
change in attachment level for patient with isolated 2 or 3 wall defect treated with enamel matrix derivative and connective tissue wall graft in 1,3 and 6 months follow up
5 secondary outcomes
pocket probing depth
Time frame: 6 months
radiographic bone gain
Time frame: 6 months
recession reduction
Time frame: 6 months
plaque index
Time frame: 6 months
gingival index
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 31 Jul 2024.
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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.
Head of the department and professor contact
Questions about this trial
What is this clinical trial studying?
A study testing Enamel matrix derivative in people with Intrabony Periodontal Defect, run by Krishnadevaraya College of Dental Sciences & Hospital.
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 6 inclusion and 6 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 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Prabhuji MLV, MDS (9448057407, prabhujimlv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical attachment gain (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 31 Jul 2024.