Edentulous Jaw Clinical Trial
Official title:
Study of Hard and Soft Tissue Behavior Around Abutments on Implants: Randomized Clinical Trial.
Verified date | June 2023 |
Source | Universitat Internacional de Catalunya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Purpose: To compare the loss of peri-implant tissue by means of radiographic and digital analysis of a zirconia prosthesis placed immediately and delay loading. Materials and methods: 60 consecutive patients with the need for a full-arch rehabilitation were selected and divided randomly into two groups: Group A: Conventional dental extraction, placement of 6 to 8 implants. Placement of the multi-unit prosthetic attachment and finally in the same week the placement of the definitive monolithic zirconia prosthesis on implants. Group B: Conventional dental extraction, placement of 6 to 8 implants. Placement of prosthetic and provisional attachment. After 3 months, place the definitive prosthesis. Assess volumetric changes using radiographic and optical scan techniques. The number of implant failures, prosthetic incidents and bone loss around the implants will be evaluated. The data will be evaluated 3, 6, and 12 months after the operation.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria of the subjects: - At least 18 years of age - Physically and mentally capable of completing the 1-year follow-up - With a stable occlusal relationship with or without opposing dentition - Are willing and able to comply with study-related procedures - Have good oral hygiene - Present good quality and quantity of bone for implant placement. - Must be American Society of Anesthesiologists (ASA) physical status of I or II, periodontal stable, and can enroll in a periodontal maintenance program. Exclusion Criteria: - Health conditions that do not permit surgical or restorative procedures (including anesthesia). - Disorder in the planned implant area (eg, previous tumors, chronic bone disease, or previous irradiation). - History of alcohol or drug abuse - Smoke more than one pack of cigarettes per day (> 20 cigarettes or equivalent) - Uncontrolled diabetes - Bisphosphonate therapy - Pathologic occlusion, (eg, severe bruxism or other parafunctional habits) - Lack opposing dentition or has unstable occlusion - Needs of bone augmentations or sinus lift treatments - Ongoing infections or endodontic or periodontal problems in opposing teeth or implants - Poor oral hygiene - Allergic or adverse reactions to the restorative material. |
Country | Name | City | State |
---|---|---|---|
Spain | Clinica Universitaria d'Odontologia | Sant Cugat del Vallés | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Universitat Internacional de Catalunya |
Spain,
Espona J, Roig E, Ali A, Roig M. Immediately loaded interim complete-arch implant-supported fixed dental prostheses fabricated with a completely digital workflow: A clinical technique. J Prosthet Dent. 2020 Oct;124(4):423-427. doi: 10.1016/j.prosdent.2019.08.008. Epub 2019 Dec 18. — View Citation
Gomez-Polo M, Ballesteros J, Perales-Padilla P, Perales-Pulido P, Gomez-Polo C, Ortega R. Guided implant scanning: A procedure for improving the accuracy of implant-supported complete-arch fixed dental prostheses. J Prosthet Dent. 2020 Aug;124(2):135-139. doi: 10.1016/j.prosdent.2019.09.022. Epub 2019 Nov 21. — View Citation
Meneghetti P, Moura GF, Tavelli L, Li J, Siqueira R, Wang HL, Mendonca G. A fully digital approach for implant fixed complete dentures: A case report. J Esthet Restor Dent. 2021 Dec;33(8):1070-1076. doi: 10.1111/jerd.12798. Epub 2021 Jul 2. — View Citation
Suarez-Feito JM, Sicilia A, Angulo J, Banerji S, Cuesta I, Millar B. Clinical performance of provisional screw-retained metal-free acrylic restorations in an immediate loading implant protocol: a 242 consecutive patients' report. Clin Oral Implants Res. 2010 Dec;21(12):1360-9. doi: 10.1111/j.1600-0501.2010.01956.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall result of final prosthesis | The final prosthesis will be judged by the patient. A 10 cm Visual analogue scale (VAS) is used. 0 (unacceptable) is placed in left end, and 10 (perfect) is placed in the right end. | One day | |
Primary | Gingival index | The Gingival Index will be assessed according to a modified version of Loe and Silness and scored as: 0 = normal mucosa, 1 = bleeding with superficial probing, or 2 = spontaneous bleeding. | One day | |
Primary | Patient satisfaction | Patient satisfaction will be evaluated separately in function and esthetics using a scale with ratings of 0 to 10 where 10 = fully satisfied and 0 = not satisfied. | One day | |
Primary | Bone-implant contact | A single independent calibrated examiner will made linear measurements on each periapical radiograph from the most mesial and distal point of the implant platform to the crestal bone. | One day |
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