Partial-edentulism
Conditions
Keywords
guided surgery, xenogenic graft, augmentation, surface scanning, Laser Speckle Contrast Imaging
Brief 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.
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.
Interventions
PROCEDURESplit-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.
PROCEDUREFull-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.
Sponsors
Geistlich Pharma AG
Institut Straumann AG
Dicomlab Kft.
Semmelweis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants are not aware of the randomly assigned flap design. Independent examiners are not aware of patient allocation during analysis of clinical and radiographic data.
Intervention model description
Test 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. Control 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Orovestibular ridge width | 6 months postoperatively | 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. |
| Dimensional change of keratinized Gingiva | 6 months postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histomorphometrical analysis | Following reentry 6 months after augmentation | Percentage of newly formed bone, bone substitute and connective tissue |
| Gingival blood flow measurement at the early wound healing phase | Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries. | Investigation of pre- and postoperative gingival blood flow using Laser Speckle Contrast Imager. |
Countries
Hungary
Contacts
Primary ContactBálint Molnár, DMD, PhD
Outcome results
None listed