Randomized Controlled Clinical Trial of CAD/CAM and Conventionally Fabricated Singl Implant Abutments.

NCT01229995 | Unknown DMC

• 1 other identifier: M17719-104
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

CAD/CAM technology has been introduced to the field of implant dentistry in the beginning of 1990's (Priest 2005). Since their introduction, the use of CAD/CAM technology in the production of dental implant restorations has been rapidly expanding. However, little evidence is currently present supporting its clinical viability (Henriksson 2003, Canullo 2007). Therefore, the suggested prospective randomized study includes bone level placed Straumann implants restored with transmucosal elements and crowns fabricated using either CAD/CAM "Etkon" technology (Zirconia abutment and ceramic crown) or a conventional technique (Crossfit titanium abutment and a ceramometal crown). The aim of this randomized controlled clinical trial is to examine single-tooth implant restorations in the esthetic zone. An esthetic area is defined as any area that is visible in the patient's full smile. \[3rd ITI consensus conference 2004\] The rehabilitations will be fabricated using two different techniques. Zirconia CAD/CAM (ZCC) implant restorations (tests) will be compared to Titanium conventionally-fabricated (TCF) implant restorations (controls) using, reproducible esthetic (objective/subjective) and biologic parameters. This in vivo study is a randomized study with two groups of 15 patients with one implant each for a total of 30 patients and 30 implants. The implants will be examined for successful tissue integration according to the criteria of success (Buser et al. 1990) at every recall visit. In addition, the following parameters will be evaluated for each restoration:

• Esthetic: A. Objective: PES/WES Score (Belser et al. 2009) from 1:1 digital photograph, study casts, and spectrophotometric measurements, and B. Subjective: VAS questionnaire for patients and VAS questionnaire from experts.
• Biologic (mPI, mB, simplified GI, microbial sample, periapical radiograph for DIB, and width of keratinized facial mucosa) Finally, an evaluation of the mechanical, biologic and technical complications will be performed at every recall visit. Mechanical complications would be defined as those complications that involve the prosthesis such as abutment screw loosening, fracture of the veneer material, fracture of the crown framework, abutment screw fractures, and implant fractures. The category of biologic complications will include those complications that involve the soft tissues (e.g., fistula, suppuration, bleeding, gingival inflammation, and soft tissue dehiscence). Technical complications are defined as those related to restorative components and crowns (e.g. crown emergence profile, abutment and crown fit, screw loosening, ceramic fracture).

Conditions

Missing Teeth; Teeth Replacemnt by Single Dental Implant; Zirconia Abutment; Titanium Abutment

Outcome Measures

Primary Outcomes (1)

• The aim of this randomized controlled clinical trial is to examine single-tooth implant abutments and restorations in the esthetic zone.

Secondary Outcomes (1)

• Test group will achieve better biologic and esthetic outcomes when compared to control group

Study Arms (1)

Prefabricated Abutment

ACTIVE COMPARATOR

Device: dental implants - zirconia abutmetns - prefabricated abutments

Interventions

dental implants - zirconia abutmetns - prefabricated abutments DEVICE

Prefabricated Abutment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General:
• Age \> 21 years
• Absence of relevant medical conditions
• Absence of periodontal diseases
• The opposing dentition must be natural teeth or fixed (not removable) restorations on teeth or implants.
• Availability for 5-year follow-up
• Local:
• One missing tooth in the esthetic zone. An esthetic area is defined as any area that is visible in the patient's full smile. \[3rd ITI consensus conference 2004\]
• Presence of two intact adjacent teeth which are either non-restored or with minor restorations (small composite restorations)
• Adequate native bone to achieve primary stability
• Adequate band of keratinized mucosa (at least 2mm)
• Full Mouth Plaque Scores (FMPS) and Full Mouth Bleeding Scores (FMBS) \< 25 %

You may not qualify if:

• General:
• Heavy smokers (more than 10 cigarettes/day)
• Presence of conditions requiring chronic prophylactic use of antibiotics
• Medical conditions requiring prolonged use of steroids.
• History of radiation therapy to the head or neck or history of chemotherapy.
• Physical handicaps that would interfere with the ability to perform adequate oral hygiene.
• Patients with inadequate oral hygiene.
• Local:
• \. Adjacent implant 2. Presence of periapical radiolucencies at the adjacent teeth 3. Missing adjacent teeth 4. Local inflammation, including untreated periodontitis. 5. Persistent intraoral infections. 6. Untreated mucosal diseases.

Sponsors & Collaborators

• Harvard School of Dental Medicine: lead

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• German O. Gallucci, DMD Dr.Med.Dent.

  Harvard School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: October 28, 2010
• Study Start: May 1, 2009
• Last Updated: October 28, 2010

Record last verified: 2010-10