Jaw, Edentulous, Partially Clinical Trial
Official title:
Implant Retained Rehabilitation With Surgical and Prosthetic Digital Workflow: A Randomized Clinical Trial
Verified date | November 2023 |
Source | Neodent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to prospectively collect clinical data to confirm the safety and clinical performance of Neodent Titanium Base Abutment and Pro PEEK Abutment in daily dental practice setting, by means of a randomized clinical study of prosthetic rehabilitation using these devices. A total of 48 healed implant sites (at least 4 months post-extraction) shall be included during the sample enrollment (24 patients), which will be randomly divided into two groups, so that each patient receives one implant from each group (removal and non-removal of the abutment placed at the time of surgery). Patients will be followed for 24 months after implant loading. It is expected that there is no difference in peri-implant bone level change between the two treatment groups.
Status | Active, not recruiting |
Enrollment | 18 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years of age or older; - 2 upper posterior teeth missing, with adjacent natural tooth; - Healed implant sites (at least 4 months post-extraction); - Qualify for placement of 4.0x10 mm Neodent GM Helix implants; - Adequate bone height to allow the 2mm subcrestal placement of a 10-mm-long implant. Exclusion Criteria: As exclusion criteria, solely the device contraindications according to the IFU (instructions for use) will be applied: - Signs of allergy or hypersensitivity to the chemical ingredients of the materials: titanium, titanium alloy (Ti6Al4V-ELI) or PEEK (Polyetheretherketone); - Presence of acute inflammatory or infectious processes in live tissue; - Unsuitable bone volume or quality; - Serious medical problems (e.g. bone metabolism disorders, blood clotting disorders, unsuitable healing capacity); - Insufficient oral hygiene; - Incomplete jawbone growth; - Patient uncooperative and not motivated; - Abuse of drugs or alcohol; - Psychosis; - Prolonged functional disorders which resist any treatment with medications; - Xerostomia; - Weakened immunological system; - Diseases which require the use of steroids; - Uncontrolled endocrinological diseases; - Pregnancy. |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO) | Curitiba | Paraná |
Lead Sponsor | Collaborator |
---|---|
Neodent |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Prosthetic success | Success will be defined as the prosthesis that remained unchanged and did not require any intervention, except routine occlusal adjustments, during the entire observational period. | 2, 6, 12 and 24 months after implant loading | |
Other | Patient Satisfaction: OHIP-14 (Oral Health Impact Profile) questionnaire | The Portuguese translation of OHIP-14 [18,19] questionnaire will be used to assess Oral Health Related Quality of Life (OHRQoL), as a measure of patient satisfaction with treatment. Scores will range from 0 (absence of negative impacts on oral health) to 28 (high frequency of negative impacts on oral health). | Baseline, 2, 6, 12 and 24 months after implant loading | |
Other | Clinician Satisfaction: VAS (Visual Analogue Scale) questionnaire | The assessment will be performed by means of a questionnaire using a visual analog scale (VAS) in the form of a 10 cm horizontal line, where 0 (left end) indicates minimum satisfaction and 10 (right end) indicates maximum satisfaction. The clinician will be instructed to mark the position considered to best represent their degree of general satisfaction with patient treatment. The score will be measured in centimeters from the left end of the line to the marked point. | Baseline, 21 days, 2, 6, 12 and 24 months after implant loading | |
Other | Rate of adverse events related to the implant, prosthesis, surgery and oral health | Determined by patient assessment. | Throughout study, up to 24 months after implant loading | |
Other | Keratinized Tissue Width | Probes calibrated at 1, 2, 3, 5, 7, and 10 mm will be used to measure keratinized tissue width as the distance from the gingival margin to the mucogingival junction, at the mid-buccal point. | Baseline, 21 days, 2, 6, 12 and 24 months after implant loading | |
Primary | Amount of peri-implant bone level change | Peri-implant bone level will be measured on the periapical radiographs obtained as the distance between the coronal margin of the implant shoulder and the most coronal point of the peri-implant bone, on the mesial and distal surfaces of each implant. The horizontal measurement of the remodeling will be done, when there is no bone contact in the cervical part of the implant. This measurement will be performed from the superior site of the bone crest to the lateral edge of the implant, perpendicular to the long axis of the implant. | 2, 6, 12 and 24 months after implant loading | |
Secondary | Implant survival | Implant survival will be defined as no loss of the implant at each follow-up. | 2, 6, 12 and 24 months after implant loading | |
Secondary | Implant success | Evaluation of implant success will be assessed based on the criteria proposed by Buser et al. | 2, 6, 12 and 24 months after implant loading | |
Secondary | Prosthetic survival | Prosthetic survival will be assessed as the prosthesis remaining in situ at each follow-up, irrespective of its condition. | 2, 6, 12 and 24 months after implant loading |
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