Modified Entire Papilla Preservation Technique For Treatment Of Intrabony Defects. Clinical Trial.

Last updated: October 11, 2021
Sponsor: Medical University of Warsaw
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

N/A

Clinical Study ID

NCT05029089
WUM.Perio.04
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Regeneration of periodontal tissues is the primary goal of periodontal surgery regenerative procedures. Most techniques include an incision of the interdental papilla associated with defect. That may impair the volume and integrity of interdental tissues. Azzi et al. proposed a novel technique (Entire Papilla Preservation Technique, EPPT) for bone regeneration to secure the integrity of interdental papillae.

This study will search for differences in regeneration therapy of isolated interdental intrabony between Modified Entire Papilla Preservation Technique (MEPPT) alone and combined with EMD, demineralised freeze- dried bone allograft and sCTG. Moreover the aim of this study was to evaluate the clinical applicability and one- year outcomes in the regenerative treatment of isolated deep intrabony defects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years (age 18-60 years), both genders
  • Good compliance and good oral hygiene
  • Systemically healthy
  • Isolated intrabony defect of more than 3 mm depth, combined with more than 6 mmprobing depth and attachment loss (stage III/IV periodontitis)
  • The area of the intrabony defect should not exceed the lingual surface area of theroot
  • The morphology of the intrabony defect will be detected during the operation andfinally determined whether the patient would be enrolled in the trial.
  • The associated tooth should either maintain normal pulp vitality or should haveundergone root canal therapy for at least 6 months before.

Exclusion

Exclusion Criteria:

  • Full-mouth plaque index ≥ 20% (Ainamo & Bay 1975)
  • Full-mouth sulcus bleeding index ≥ 15% (Mühlemann & Son 1971)
  • Smoking
  • Systemic diseases with compromised healing potential of infectious diseases
  • Drugs affecting periodontal health / healing
  • Pregnant and lactating females
  • Previous periodontal surgery in the examined area
  • Affected teeth with 3° mobility
  • Furcation involvement
  • Acute periapical inflammation

Study Design

Total Participants: 15
Study Start date:
September 10, 2021
Estimated Completion Date:
September 01, 2023

Study Description

Regeneration of periodontal tissues is the primary goal of periodontal surgery regenerative procedures. Both resorbable and nonresorbable barrier membranes have been widely used to receive periodontal regeneration, as well as different types of biomaterial have been investigated. Enamel matrix derivative (EMD, Emdogain, Straumann) become popular for periodontal regeneration, especially that membrane exposure due to bacterial contamination may deteriorate periodontal regeneration and wound healing especially in the interproximal areas. Hence different surgical procedures have been proposed to preserve interdental papilla. Most techniques include an incision of the interdental papilla associated with defect. That may impair the volume and integrity of interdental tissues. Azzi et al. proposed a novel technique (Entire Papilla Preservation Technique, EPPT) for bone regeneration to secure the integrity of interdental papillae by providing a tunnel- like undermining incision.

The completely preserved papillae improve wound healing process, stabilize the blood clot and the volume of interdental tissue. EMD and bone substitutes (allograft) are applied in the defect to promote periodontal regeneration. By using subepithelial connective tissue graft (sCTG) better quality (thickness) of soft tissue can be achieved. This clinical report describes surgical approach using modified papilla preservation technique for regenerative periodontal therapy. This study will search for differences in regeneration therapy of isolated interdental intrabony between Modified Entire Papilla Preservation Technique (MEPPT) alone and combined with EMD, demineralised freeze- dried bone allograft and sCTG. Moreover the aim of this study was to evaluate the clinical applicability and one- year outcomes in the regenerative treatment of isolated deep intrabony defects.

Connect with a study center

  • Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw

    Warsaw, Mazowsze 00-246
    Poland

    Active - Recruiting

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