Reconstruction of Localized Alveolar Ridge Defects

Comperative Clinical, Microcircular, Surface Scanning, Radiological and Histological Evaluation of Two Different Flap Techniques - A Prospective Randomized Clinical Trial/

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.

Study Overview

• Status: Recruiting
• Conditions: Partial-edentulism
• Intervention / Treatment: Procedure: Split-thickness group; Procedure: Full-thickness group

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Balint Molnar, DMD, PhD; Phone Number: 0036302553334; Email: molbal81@gmail.com

Study Locations

• Hungary
  • Budapest, Hungary, 1088
    • Recruiting
    • Semmelweis University Department of Periodontology
    • Contact: Balint Molnar, DMD, PhD; Phone Number: 0036302553334; Email: molbal81@gmail.com
    • Principal Investigator: Balint Molnar, DMD, Phd
    • Contact: Peter Windisch, DMD, PhD; Phone Number: 0036208250310; Email: peter.windisch@gmail.com
    • Sub-Investigator: Peter Windisch, DMD, PhD
    • Principal Investigator: Ferenc Bartha, DMD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

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 bone metabolism
• Clinically significant circulatory disorders such as decompensated cardiac failure
• Haemodynamically significant heart failure or myocardial infarction within the last 3 months
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Split-thickness group; Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a split-thickness flap design in the posterior maxilla or mandible in partially edentolous patients.	Procedure: Split-thickness group; Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a split-thickness flap design in the posterior maxilla or mandible in partially edentolous patients.
Experimental: Full-thickness group; Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a full-thickness flap design in the posterior maxilla or mandible in partially edentolous patients.	Procedure: Full-thickness group; Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a full-thickness flap design in the posterior maxilla or mandible in partially edentolous patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orovestibular ridge width	On prealigned pre- and postoperative CBCT cross-sections, linear measurements were taken parallel to a reference base to determine the orovestibular width of the surgical area.	6 months postoperatively
Dimensional change of keratinized Gingiva	Pre-and postoperatively a surface scan is performed using a Planmeca Emerald intraroral scanner. The superimposition of the measurements was used to evaluate the soft tissue changes associated with the treatments in 3 dimension.	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histomorphometrical analysis	Percentage of newly formed bone, bone substitute and connective tissue	Following reentry 6 months after augmentation
Gingival blood flow measurement at the early wound healing phase	Investigation of pre- and postoperative gingival blood flow using Laser Speckle Contrast Imager.	Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries.

Collaborators and Investigators

• Sponsor: Semmelweis University
• Collaborators: Institut Straumann AG; Geistlich Pharma AG; Dicomlab Kft.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2019
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: guided surgery; augmentation; Laser Speckle Contrast Imaging; xenogenic graft; surface scanning
• Other Study ID Numbers: Augmentation-Semmelweis-Perio

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No