tooth extraction Dental implants
Conditions
Interventions
Double-blind, two-arm randomized controlled trial. Participants will be randomly assigned to study groups using a manually established restricted list and allocation concealment will be ensured throug
Sponsors
Universidade do Estado do Rio de Janeiro
Universidade Veiga de Almeida
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria comprise participants aged over 18 years classified as ASA I or ASA II according to the American Society of Anesthesiologists presenting teeth indicated for extraction in the aesthetic zone of the maxilla involving central incisor or lateral incisor or canine or first premolar or second premolar being a single unit. Participants must present transverse root position Class I or Class II or Class III according to Kan and Class I socket with intact buccal wall or Class II socket with up to one third of the buccal wall compromised in addition to buccal recessions of up to 2.0 millimeters and sufficient bone thickness and height for immediate implant placement with primary stability possessing natural teeth adjacent to the element to be extracted.
Exclusion criteria
Exclusion criteria: Patients classified above ASA II or heavy smokers defined as those consuming over 10 cigarettes per day or with a history of radiotherapy in the head and neck region or undergoing chemotherapy for treatment of malignant tumors or patients with uncontrolled diabetes defined as glycated hemoglobin above 7.0 millimoles per liter will be excluded. Also constituting exclusion criteria are the presence of pathological soft tissue alterations in the intervention region such as leukoplakia or lichen planus or erythroplakia and extensive periapical bone pathological alterations that prevent implant placement as well as localized periodontitis in the intervention region or Stage IV Periodontal Disease without occlusal stability or Class IV sockets according to Kan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that the bovine pericardium collagen membrane (test group) will present horizontal bone thickness results non-inferior to the control membrane. Verified by means of cone-beam computed tomography (CBCT) performed at 6 months and 1 year after surgery. Based on the measurement of buccal bone thickness in millimeters at the implant platform region and at 2.0mm, 4.0mm, and 6.0mm apical to the platform. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to obtain similar peri-implant aesthetic results between test and control groups. Verified by means of objective analysis of standardized intraoral photographs using established aesthetic indices. Based on the comparison of values obtained in the Pink Esthetic Score and White Esthetic Score indices during follow-up visits.;It is expected to maintain marginal bone level stability with minimal variations and no statistically significant difference between groups. Verified by means of comparative imaging examinations (periapical radiographs and computed tomography) performed throughout the follow-up. Based on the millimetric measurement of the vertical distance between the implant platform and the adjacent bone crest (on mesial and distal aspects), quantifying the bone remodeling occurred relative to the time of placement.;It is expected to observe similar levels of postoperative morbidity and patient response to treatment in both test and control groups. Verified by means of clinical evaluation of healing and participant reports during post-surgical follow-up visits at 2 weeks, 2 months, 6 months, and 1 year. Based on the descriptive analysis of reports of symptomatology, edema, and soft tissue healing quality recorded in clinical charts. | — |
Countries
BR
Contacts
Public ContactEduardo Jose Lourenco
Universidade do Estado do Rio de Janeiro - UERJ
Outcome results
None listed