Comperative Clinical, Microcircular, Surface Scanning, Radiological and Histological Evaluation of Two Different Flap Techniques - A Prospective Randomized Clinical Trial/
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Partial-edentulism
- Sponsor
- Semmelweis University
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Orovestibular ridge width
- Status
- Recruiting
- Last Updated
- 2 years ago
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.
Investigators
Eligibility Criteria
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
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.)