Reconstruction of Localized Alveolar Ridge Defects

Partial-edentulism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05538715
• Other study ID #: Augmentation-Semmelweis-Perio
• Status: Recruiting
• Phase: Phase 4
• Start date: November 8, 2019
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: Semmelweis University
• Contact: Bálint Molnár, DMD, PhD
• Phone: 0036302553334
• Email: molbal81[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Partial-edentulism

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hungary	Semmelweis University Department of Periodontology	Budapest

Sponsors (4)

Lead Sponsor	Collaborator
Semmelweis University	Dicomlab Kft., Geistlich Pharma AG, Institut Straumann AG

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Histomorphometrical analysis	Percentage of newly formed bone, bone substitute and connective tissue	Following reentry 6 months after augmentation
Secondary	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.