Skip to content

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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06530199
Enrollment
30
Registered
2024-07-31
Start date
2024-07-31
Completion date
2025-07-31
Last updated
2024-07-31

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

Conditions

Intrabony Periodontal Defect

Brief 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 .

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.

Interventions

connective tissue graft and Enamel matrix derivative in the defect area

Sponsors

Krishnadevaraya College of Dental Sciences & Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
clinical attachment gain6 monthschange 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

Secondary

MeasureTime frameDescription
pocket probing depth6 monthschange in pocket probing depth from baseline to 1,3 and 6 months
radiographic bone gain6 monthschange in radiographic bone level from baseline to 1,3,6 months
recession reduction6 monthschange in recession from baseline to 1,3 and 6 months
plaque index6 monthschange in plaque index from baseline to 1,3 and 6 months
gingival index6 monthschange in calculus index from baseline to 1,3 and 6 months

Contacts

Primary ContactPrabhuji MLV, MDS
prabhujimlv@gmail.com9448057407
Backup ContactHead of the department and professor

Outcome results

None listed

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