Reconstruction of Localized Alveolar Ridge Defects

Last updated: November 23, 2023
Sponsor: Semmelweis University
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Full-thickness group

Split-thickness group

Clinical Study ID

NCT05538715
Augmentation-Semmelweis-Perio
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The aim of the present prospective randomized controlled study is to compare the clinical, radiological, micro-circulation, and histology of a novel, semi-thick, and conventional full-thickness mucoperiosteal flap technique during horizontal alveolar ridge augmentation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • at least one edentulous maxillary/mandibulary premolar or molar site with horizontalbone loss
  • full- mouth plaque and bleeding scores (FMPS and FMBS) <20%
  • good patient compliance (including willingness to participate in the follow-upprocedures) signed informed consent-

Exclusion

Exclusion Criteria:

  • Active infectious diseases (HBV, HCV, HIV, TB, SARS CoV-2, etc.)
  • Current chemotherapy or radiotherapy
  • Radiation treatment of the former head and neck region (not older than 2 years)
  • Untreated insulin-dependent diabetes mellitus
  • Clinically significant osteoporosis or other systemic disease affecting bonemetabolism
  • Clinically significant circulatory disorders such as decompensated cardiac failure
  • Haemodynamically significant heart failure or myocardial infarction within the last 3months
  • Clinically significant coagulation disorder
  • Current or previous systemic corticosteroid therapy (not older than 2 months)
  • Current or previous systemic bisphosphonate therapy
  • Pregnant or breastfeeding mothers
  • Smoking
  • Drug addiction, alcoholism

Study Design

Total Participants: 44
Treatment Group(s): 2
Primary Treatment: Full-thickness group
Phase: 4
Study Start date:
November 08, 2019
Estimated Completion Date:
September 30, 2024

Study Description

The aim of our study was to compare the clinical, radiological, circulatory, and histological studies of a novel, split-thickness and conventional full-thickness mucoperiosteal flap technique during horizontal alveolar ridge augmentation surgeries. Flap formation was performed in the test group using the novel split-thickness surgical technique, and in the control group using the full-thickness mucoperostatial surgical technique. The novel split-thickness flap technique to be studied results in a predictable, closed healing based on our preliminary results, thus ensuring the conditions for successful augmentation. We primarily want to investigate what hard and soft tissue changes result from ridge augmentation with a novel split-thickness flap technique after 6 months, compared to a surgical technique based on full thick flap formation accepted as a standard procedure in the literature. Our secondary examination methods: examination of early wound healing and micro-circulation after augmentation interventions by LSCI method; histological evaluation at prosthetically designed implant positions.

Connect with a study center

  • Semmelweis University Department of Periodontology

    Budapest, 1088
    Hungary

    Active - Recruiting

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