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

NCT03336723 | Unknown DMC

• 1 other identifier: II10
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Osseointegration

  measure if the healing process of bone was successful

  from T0 to T2 - 2 month

• Marginal bone loss

  measure bone level from T0 baseline to T3

  4 month after T0

• IL1b concentration

  Measure IL fluid at T0 and T2 for IL1b characterization

  4 month

• IL6 concentration

  Measure IL fluid at T0 and T2 for IL1b characterization

  4 month

• Microbiologic samples

  Measure crevicular fluid at T0 and T2 for bacteria characterization

  4 month

Study Arms (2)

Experimental Group

EXPERIMENTAL

Two piece zirconia dental implants place subcrestally with a healing abutment at baseline (T0) and rehabilitated with a zirconia dental crown T3 3 Measures on the IL1b and IL6 at T0 baseline , T2 2 month and T3 at crown placement.Microbiological samples at T2 and T3.

Device: Dental Implant

Control Group

ACTIVE COMPARATOR

Two piece titanium dental implants place subcrestally with a healing abutment at baseline (T0) and rehabilitated with a zirconia dental crown T3 3 Measures on the IL1b and IL6 at T0 baseline , T2 2 month and T3 at crown placement.Microbiological samples at T2 and T3.

Device: Dental Implant

Interventions

Dental Implant DEVICE

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

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Implantology Institute: lead

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Elena cervino, DMD

CONTACT

00351919774343; elecer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DMD

Study Record Dates

• First Submitted: November 5, 2017
• First Posted: November 8, 2017
• Study Start: January 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: January 1, 2019
• Last Updated: November 8, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share