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

NCT06530199 | Not Yet Recruiting

• 1 other identifier: 02_D012_147502
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Intrabony Periodontal Defect

Outcome Measures

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

  6 months

Secondary Outcomes (5)

• pocket probing depth

  6 months

• radiographic bone gain

  6 months

• recession reduction

  6 months

• plaque index

  6 months

• gingival index

  6 months

Study Arms (2)

control group

ACTIVE COMPARATOR

Simplified papilla preservation flap with enamel matrix derivative will be performed

Procedure: Enamel matrix derivative

Test group

EXPERIMENTAL

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

Procedure: Enamel matrix derivative

Interventions

Enamel matrix derivative PROCEDURE

connective tissue graft and Enamel matrix derivative in the defect area

Also known as: Connective tissue graft technique

Test group; control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Central Study Contacts

Prabhuji MLV, MDS

CONTACT

9448057407; prabhujimlv@gmail.com

Head of the department and professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 31, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07