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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorKrishnadevaraya College of Dental Sciences & Hospital

About this trial

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 .

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

Grade III mobility, endodontically treated teeth.

Pregnant and lactating females.

History of tobacco smoking .

Patients with systemic disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enamel matrix derivative

    Procedure/Surgery

    connective tissue graft and Enamel matrix derivative in the defect area

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: control groupActive comparator 1 intervention
Group B: Test groupExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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