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 LossGingival 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
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