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Novel Porcine Dermal Matrix in the Treatment of Multiple Adjacent Gingival Recessions

NCT03163654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-05-30

No results posted yet for this study

Summary

The aim of this study was to assess the clinical efficacy of the acellular porcine derived collagen matrix (PADM) in comparison with connective tissue graft (SCTG ) in the treatment of multiple adjacent gingival recessions (MAGR). The primary objectives of the study were to evaluate mean and complete roots coverage. Additionally, the secondary objective was to evaluate and compare the clinical effectiveness of PADM and SCTG for the treatment of MAGR defects applying modified coronally advanced tunnel technique (MCAT).

Conditions

  • Recession, Gingival

Interventions

PROCEDURE

Surgery 1

Following local anaesthesia (Articaine hydrochloride 4% with 1:200,000 epinephrine injection) administration, sulcular incisions were made in the recession's areas of teeth without damaging interdental papilla. Mucoperiosteal (MP) dissections were made using the periostal elevator creating the deep pouch beyond the mucogingival junction so that the (MP) flap could be moved coronally without tension. Porcine-derived acellular dermal collagen matrix (PADM) was positioned at the level of a cemento-enamel junction (CEJ) and skin tight for teeth to avoid forming a blood clot. Separate single sutures per tooth with 5-0 resorbable suture were used to stabilise graft. The tunnel flap was positioned coronally above the CEJ to completely cover the graft and sutured with non-resorbable polypropylene suture.

PROCEDURE

Surgery 2

Following local anaesthesia (Articaine hydrochloride 4% with 1:200,000 epinephrine injection) administration, sulcular incisions were made in the recession's areas of teeth without damaging interdental papilla. Mucoperiosteal (MP) dissections were made using the periostal elevator creating the deep pouch beyond the mucogingival junction so that the (MP) flap could be moved coronally without tension. Connective tissue graft was positioned at the level of a cemento-enamel junction (CEJ) and skin tight for teeth to avoid forming a blood clot. Separate single sutures per tooth with 5-0 resorbable suture were used to stabilise graft. The tunnel flap was positioned coronally above the CEJ to completely cover the graft and sutured with non-resorbable polypropylene suture.

Sponsors & Collaborators

  • Botiss Medical AG

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-04-30
Completion
2016-09-30

Countries

  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03163654 on ClinicalTrials.gov