Two-Piece Zirconia Dental Implant vs Two-Piece Titanium Dental Implant- Randomized Clinical Control Trial

Osseointegration Failure of Dental Implant Due to Infection Clinical Trial

Official title:

Inflammation and Microbiology Pattern on Two-piece Zirconia Dental Implant Compared to Titanium Dental Implants. Randomized Clinical Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03336723
• Other study ID #: II10
• Status: Not yet recruiting
• Phase: N/A
• First received: November 5, 2017
• Last updated: November 5, 2017
• Start date: January 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: November 2017
• Source: Instituto de Implantologia
• Contact: Elena cervino, DMD
• Phone: 00351919774343
• Email: elecer[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

2 Arms (60 subjects - 30 each arm). Experimental group with two-pice zirconia dental implant and Control group with two-piece titanium dental implant Evaluate Changes in inflammatory and microbiology levels from T0 (baseline) T2 (8 weeks) and T3 (after crown placement) Also evaluate secondary outcomes: marginal bone loss (MBL), gingival height (GH) levels, osseointegration, gender, age, time of surgery, anatomical position and implant stability. p values<0.05 were considered statistically significant

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 1, 2019
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Single implants in any area (maxillary and mandibular), extracted teeth for at least 3 months before implant placement, with bone volumes sufficient (at least 2 mm mesial, distal, buccal and palatal) to accommodate dental implant without the need for regeneration. Controlled oral hygiene, absence of any lesions in the oral cavity, at least 2 mm keratinized tissue. In addition, patients must agree to participate in a postoperative control program and signed the informed consent.

Exclusion Criteria:

1 - allergic to local anaesthetics, or any of the other components. 2 - Patients with hepatic or renal dysfunction 3 - Patients with epilepsy, shock, cardiac conduction disorders or myasthenia gravis 4 - Patients with myocardial injury 5 - Hyperthyroidism 6 - Severe Hypertension 7 - Insufficient bone volume 8 - Smoking more than five cigarettes / day 9 - Excessive alcohol consumption 10 - localized anti-tumour radiation therapy of the oral cavity 11 - Chemotherapy 12 - Liver Diseases 13 - immunosuppressed patients 14 - Patients taking corticosteroids 15 - Pregnancy 16 - inflammatory and autoimmune diseases of the oral cavity

Related Conditions & MeSH terms

• Osseointegration Failure of Dental Implant Due to Infection
• Osseointegration Failure of Dental Implant Prior to Intentional Prosthetic Loading

Intervention

Device:
• Dental Implant
Place a two piece zirconia dental implant on a healed ridge. At baseline, two month and crown placement take fluid samples with adsorbent paper in the per- implant crevicular fluid. At t2 and t3 repeat sample taken

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Implantologia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osseointegration	measure if the healing process of bone was successful	from T0 to T2 - 2 month
Primary	Marginal bone loss	measure bone level from T0 baseline to T3	4 month after T0
Primary	IL1b concentration	Measure IL fluid at T0 and T2 for IL1b characterization	4 month
Primary	IL6 concentration	Measure IL fluid at T0 and T2 for IL1b characterization	4 month
Primary	Microbiologic samples	Measure crevicular fluid at T0 and T2 for bacteria characterization	4 month