Comperative Clinical, Microcircular, Surface Scanning, Radiological and Histological Evaluation of Two Different Flap Techniques - A Prospective Randomized Clinical Trial/
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Semmelweis University
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Orovestibular ridge width
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, 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.
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Drug addiction, alcoholism
Arms & Interventions
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.
Intervention: Split-thickness group (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.
Intervention: Full-thickness group (Procedure)
Outcomes
Primary Outcomes
Orovestibular ridge width
Time Frame: 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
Time Frame: 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 Outcomes
- Histomorphometrical analysis(Following reentry 6 months after augmentation)
- 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.)