Volumetric Changes of Labial Soft Tissue Contour Following Different Approaches With Immediate Im… (NCT04310449) | Clinical Trial Compass
CompletedNot Applicable
Volumetric Changes of Labial Soft Tissue Contour Following Different Approaches With Immediate Implant Placement
Egypt30 participantsStarted 2020-07-01
Plain-language summary
Statement of the problem: Tooth extraction is followed by ridge alteration and soft tissue contour collapse. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue contour and to maintain long term stability is unclear. Purpose : The aim of this study is to evaluate the volumetric difference of buccal soft tissue contour as well as the radiographic changes, following tooth extraction and immediate implant placement with dual zone concept versus connective tissue graft. Materials and Methods: Thirty patients with single maxillary anterior or premolar tooth indicated for extraction will participate in this study, 15 patient in each group. Group 1 (test group) will be treated by immediate implant placement (IIP) with particulate bone grafts in the dual zone (the bone zone and the tissue zone) and customized healing abutment. Group 2 (control group) IIP with connective tissue graft (CTG) and customized healing abutment. Patient allocation is random for the 2 groups. Data will be collected pre-surgically and at follow up periods (3,6,9\&12 months and 6 months after delivery). Extra-oral scanning of the labial contour will be carried out to evaluate difference in contour gained and will be compared to the original contour and between treatment groups. Radiographic evaluation will be done using CBCT pre-operatively and at 12 months.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Patients who have at least one non-restorable maxillary anterior or premolar tooth with sound adjacent teeth.
✓. Adults at or above the age of 18.
✓. Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
✓. Buccal bone thickness should be 1mm or less assessed in CBCT with good apical bone.
✓. Sagittal root position type 1 as described by Kan et al(30).
✓. Good oral hygiene
✓. Patient accepts to provide an informed consent.
Exclusion criteria
✕. Smokers
✕. Pregnant and lactating females.
✕. Medically compromised patients. , as Uncontrolled diabetic patients, patients taking bisphosphonates injection for treatment of osteoporosis, patients with active cardiac diseases, patients undergoing radiotherapy or chemotherapy, or any other medical and general contraindications for the surgical procedure (i.e. ASA score ≥III) (31)
What they're measuring
1
Pink Esthetic Score (PES)
Timeframe: 6 months after delivery (18 months after IIP)