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NCT Number: NCT06530199

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

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 .

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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 .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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enamel matrix derivative

Procedure

connective tissue graft and Enamel matrix derivative in the defect area

Other names: Connective tissue graft technique

Primary outcomes

  1. 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

Secondary outcomes

  1. pocket probing depth

    Time frame: 6 months

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

  2. radiographic bone gain

    Time frame: 6 months

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

  3. recession reduction

    Time frame: 6 months

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

  4. plaque index

    Time frame: 6 months

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

  5. gingival index

    Time frame: 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Head of the department and professor

CONTACT

Prabhuji MLV, MDS

CONTACT

[email protected]

9448057407

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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