Marginal Bone Level Around Titanium Implants Produced by Additive Manufacture

Dental Implants Clinical Trial

Official title:

Evaluation of the Marginal Bone Level of Titanium Implants Produced by Additive Manufacture, in 30 and 90 Days: Randomized Within-subject Clinical Trial of 1-year Non-inferiority

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627037
• Other study ID #: 59844422.4.0000.0075
• Status: Recruiting
• Phase: N/A
• Start date: November 2022
• Est. completion date: June 2024

Study information

• Verified date: November 2022
• Source: University of Sao Paulo
• Contact: Giuseppe A Romito, PhD
• Phone: +5511 30917833
• Email: garomito[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study will be to evaluate the non-inferiority of implants produced by additive manufacture loaded in 30 days when compared with those loaded in 90 days, in relation to marginal bone loss, after 01 (one) year of follow-up

Description:

This randomized Split-mouth clinical study of non-inferiority will monitor for one year partially edentulous patients in the posterior region of the mandible or maxilla, rehabilitated with 2 implants (AM) in the same Arch to evaluate the success rate of the implant, one loaded at 30 days after installation and the other at 90 days. Changes in marginal bone level and osseointegration success will be evaluated, with visits and data collection in 0 days (baseline), 30 days, 90 days, 6 months and 1 year

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients treated and referred by the Dental Clinic of the School of Dentistry of the University of São Paulo;
• Individuals over 18 years and under 70 years of age;
• Good general health;
• signed Informed Consent Form;
• Need for rehabilitation with dental implants in areas of mandible or posterior maxilla (premolars and/or molars);
• bacterial plaque index = 20% (Silness & Loe, 1964);
• bleeding rate of = 20% (Loe & Silness, 1963);
• Sufficient alveolar bone volume for an implant of:
• Length: 8 or 10mm
• Diameter: 3.5mm, 4. 00mm or 4. 5mm
• Bone quality type I-III;
• No associated bone regeneration.

Exclusion Criteria:

• Pregnant and lactating women;
• Uncontrolled diabetes;
• History of chemotherapy or radiotherapy in the last 5 years;
• Radiotherapy in areas of the head and neck;
• Use of immunosuppressants, bisphosphonate or prolonged use of corticosteroids;
• Smokers;
• Alcohol or drug abuse;
• Untreated periodontitis;
• History of previous bone increase in the implant installation region;
• Presence of residual roots at the site receiving the implant;
• Bone density type IV
• Individuals with connective tissue disorders or metabolic diseases;
• Postmenopausal osteoporosis or other systemic diseases that may affect bone metabolism;
• Need for guided bone regeneration at the time of implant installation.

Related Conditions & MeSH terms

• Dental Implants

Intervention

Device:
• Dental implant produced by additive manufacture
In a split-mouth setup, each participant will receive two implants in the posterior region of the mandible or maxilla. After implant insertion, one implant will be randomly allocated to receive Temporary restoration after 30 days and definitive restoration after 90 days
• Dental implant produced by additive manufacture
In a split-mouth setup, each participant will receive two implants in the posterior region of the mandible or maxilla. After implant insertion, one implant will receive definitive restoration after 90 days

Locations

Country	Name	City	State
Brazil	School of Dentistry - University of São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Plenum (M3 Health Industria e Comercio de Produtos Médicos)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal Bone Loss (MBL)	Digital periapical radiographs will be taken at the implant installation (baseline) after 1 year. The radiographs will be taken using the parallelism technique with a positioner that supports the digital sensor in order to standardize the radiographs.	1 year
Secondary	Implant success rate	The success rate or failure of each implant in clinical and radiographic findings will be classified using the success criteria defined by Buser et al. (1990); Absence of persistent subjective complaints, such as pain, foreign body sensation and/or dysesthesia.; Absence of a recurrent peri-implant infection with suppuration.; Absence of mobility.; Absence of a continuous radiolucency around the implant.; Possibility for restoration. These criteria will be monitored at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year	1 year
Secondary	Modified Plaque Index (mPI)	Modified Plaque Index (Mombelli, Van Oosten Et.Al 1987): Scoring Criteria: Score 0: No detection of plaque Score 1:Plaque only recognized by running a probe across the smooth marginal surface of the implant Score 2: Plaque can be seen by the naked eye. Score 3: Abundance of soft matter. The changes in Modified Plaque Index (mPI) will be monitored at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year	1 year
Secondary	Modified Bleeding Index (mBI)	Modified Sulcus Bleeding Index (Mombelli, Van Oosten Et.Al 1987): Scoring Criteria: Score 0: No bleeding when probe is passed along the gingival margin. Score 1: Isolated bleeding, spots present. Score 2: Blood forms a confluent red line on margins. Score 3: Heavy or profuse bleeding. The changes in Modified Bleeding Index (mBI) will be monitored by a blinded calibrated examiner at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year	1 year
Secondary	Pocket probing depth (PPD)	Pocket Probing Depth (PPD) will be measured by a blinded calibrated Examiner, and The changes in Pocket Probing Depth (PPD) will be monitored at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year	1 year
Secondary	clinical attachment level (CAL)	Clinical attachment level (CAL) will be measured by a blinded calibrated Examiner, and The changes in clinical attachment level (CAL) will be monitored at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year	1 year