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Healing of Bone/Soft Tissue to Different Abutment Biomaterials and the Impact on Marginal Bone Loss

Information source: Instituto de Implantologia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bone Loss; Inflammation

Intervention: dental implants (Device); Zirconia abutments (Device); Titanium Abutments (Device); acrylic abutments (Device); cad-cam acrylic abutments (Device); Subcrestal (Procedure); platform-switch (Device); one-time one-abutment (Procedure); Torque 20 n/cm2 (Procedure)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Instituto de Implantologia

Official(s) and/or principal investigator(s):
Andre Chen, Msc, Principal Investigator, Affiliation: Instituto de Implantologia
João Caramês, Phd, Study Director, Affiliation: Instituto de Implantologia
Elena Cervino, Msc, Study Chair, Affiliation: Instituto de Implantologia
Helena Francisco, Msc, Study Chair, Affiliation: Instituto de Implantologia

Overall contact:
Andre Chen, Msc, Phone: 00351919774343, Email: tsouchen@gmail.com

Summary

In patients that require a dental implant, does zirconia compared to titanium, acrylic or cad-cam acrylic abutments, provide less inflammation, marginal bone loss or infection during the osseointegration period ?

Clinical Details

Official title: Healing Response if Peri-implant Tissues to Different Abutment Materials - Double-blinded Randomized Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Gingival Inflammatory Changes from baseline to 12 weeks

Secondary outcome:

Marginal Bone Loss

Gingival height

Osseointegration

Height from gingiva to abutment

Detailed description: Place dental Implants and zirconia, titanium, acrylic or cad-cam acrylic abutments, torque to 20 n/cm2 Evaluate Changes in inflammatory levels from T0 (baseline) to T7-12 weeks (measure intermediate points at T0 (baseline),T1-1 week,T2-2weeks, T3-3 weeks, T4-4 weeks, T5-6 Weeks,T6-8 Weeks and T7-12 weeks) Also evaluate outcomes marginal bone loss, gingival height levels and osseointegration

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Single unit implant rehabilitation

- Maxilla and mandible

- Must accept treatment plan

- Must sign informed consent

- dental extraction performed at least 3 month prior

- Must have at least 6 mm of residual bone

- Absence of oral lesions

- keratinized tissue must be present

Exclusion Criteria:

- If smoking and/or other drug addiction is present

- If local anesthetic allergy is present

- Patient subjected to chemical or radiotherapy

- if Hepatic disease is present

- If immunodepression is present

- If Pregnancy is present

- If Diabetes is present

- If Heart disease is present

Locations and Contacts

Andre Chen, Msc, Phone: 00351919774343, Email: tsouchen@gmail.com

Instituto de implantologia, Lisbon 1500-662, Portugal; Not yet recruiting
Joana Velez, Phone: 00351217 210 980, Email: joana.velez@institutodeimplantologia.com
Andre Chen, Msc, Principal Investigator
João Caramês, Phd, Principal Investigator
Elena Cervino, Msc, Sub-Investigator
Helena Francisco, Msc, Sub-Investigator
Additional Information

Starting date: January 2014
Last updated: October 9, 2013

Page last updated: August 23, 2015

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