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Not yet recruitingNCT06530199Updated Jul 31, 2024

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

An interventional study of Enamel matrix derivative in Intrabony Periodontal Defect, sponsored by Krishnadevaraya College of Dental Sciences & Hospital. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Krishnadevaraya College of Dental Sciences & Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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 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.

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Conditions studied

  • Intrabony Periodontal Defect
03

In context

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital is the lead sponsor of 51 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Grade III mobility, endodontically treated teeth.
  • Pregnant and lactating females.
  • History of tobacco smoking .
  • Patients with systemic disease.
  • Known allergy or to EMD.
  • Presence of pulpal and peri apical involvement
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    control group

    Simplified papilla preservation flap with enamel matrix derivative will be performed

    Procedure: Enamel matrix derivative

  • Experimental
    Test group

    Simplified papilla preservation flap with connective tissue graft and enamel matrix derivative will be performed

    Procedure: Enamel matrix derivative

Interventions

  • ProcedureEnamel matrix derivative

    connective tissue graft and Enamel matrix derivative in the defect area

    Also known as: Connective tissue graft technique

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

  1. pocket probing depth

    change in pocket probing depth from baseline to 1,3 and 6 months

    Time frame: 6 months

  2. radiographic bone gain

    change in radiographic bone level from baseline to 1,3,6 months

    Time frame: 6 months

  3. recession reduction

    change in recession from baseline to 1,3 and 6 months

    Time frame: 6 months

  4. plaque index

    change in plaque index from baseline to 1,3 and 6 months

    Time frame: 6 months

  5. gingival index

    change in calculus index from baseline to 1,3 and 6 months

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06530199
Lead sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Responsible party
Sponsor
First posted
Jul 31, 2024
Start date
Jul 2024 (estimated)
Primary completion
Jul 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Jul 31, 2024

Study contacts

Prabhuji MLV, MDS
Contact
prabhujimlv@gmail.com
9448057407
Head of the department and professor
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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