Soft and Hard Tissue Changes Around the New Lance® Implants Using Traditional and Switch Platform Abutments

Group A- 23 Implant Using Switch Platform -SPK Abutment. Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01234584
• Other study ID #: CTIL0227-10-RMB
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2010
• Last updated: December 7, 2010
• Start date: September 2010

Study information

• Verified date: September 2010
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: IRB
• Study type: Interventional

Clinical Trial Summary

The purpose of this present study is to compare alveolar bone changes and markers of gingival health around the new Lanes® dental implant which were rehabilitate using the new switch platform abutment ( SPR ) and the traditional ( CPK ) abutment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Adult patient aged 18 - 80 yrs.

2. Implants treatment planned for single crown rehabilitation.

3. Submerged implant placement.

4. Patients willing to participate in a twelve month study.

5. Up to 2 implants per patient will be allowed.

Exclusion Criteria:

1. Active periodontal disease.

2. Systemic condition and medication that may affect soft and hard tissue healing.

3. Pregnancy or intention to become pregnant in the next twelve months.

4. Parafunctional occlusal scheme and habits.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Group A- 23 Implant Using Switch Platform -SPK Abutment.
• Group B- 22 Implant Using the Traditional -CPK Abutment.

Intervention

Procedure:
• spk
implants using SPK Abutments
• CPK Abutments
implants using CPK Abutments

Locations

Country	Name	City	State
Israel	Department of Maxillofacial Rehabillitaion School of Graduate Dentistry Rambam Health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue evaluation:	Three month following abutment connection (approximately 2 months following cementation of the final crowns) baseline measurement will be taken. This will include probing pockets depth (PPD) and bleeding on probing (BOP) dichotomized in to 0 and 1 This measurement will be repeated at 12 month post surgery.	12 month	Yes
Primary	Radiographic evaluation:	Bite wing radiographs will be used to assess changes in radiographic bone height.; Baseline radiographs will be taking immediately following abutment connection and final radiographic evaluation will be taken 12 months post surgery.	12 month post surgery	Yes