The Influence of a New Implant Neck Configuration on Hard and Soft Tissue Healing
1 other identifier
interventional
52
1 country
1
Brief Summary
Title: Randomized Controlled Clinical Trial comparing two dental implants with different neck configurations. Objective: To evaluate the changes in peri-implant soft tissues and marginal bone level when using a one-piece implant with a widening transgingival machined collar and a one-piece implant with a tapering transgingival machined collar. Design: The study will be a prospective parallel randomized clinical trial with a 12 month follow up conducted in 5 private dental practices. A total of 50 patients meeting the inclusion criteria will be randomized in one of the two groups to receive 1 single implant placed in healed ridges. Radiographic and clinical measurements will be taken post-insertion, baseline (post-loading) 6 and 12 months after loading. Study Hypothesis: The hypothesis of this study is that there will be no differences in the preservation of the peri-implant marginal bone level and peri-implant soft tissues between the two implant neck designs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 17, 2019
CompletedFirst Submitted
Initial submission to the registry
October 27, 2019
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2021
CompletedMarch 13, 2020
March 1, 2020
1.4 years
October 27, 2019
March 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
soft tissue volumetric changes
soft tissue volumetric changes between baseline and one year
1 year
Secondary Outcomes (5)
marginal bone levels
1 year
implant survival rate
1 year
probing pocket depth
1 year
recession
1 year
keratinized mucosa
1 year
Study Arms (2)
convergent neck
ACTIVE COMPARATORGroup A Sweden \& Martina Prama (P). Transgingival tapering machined collar, 2.8 mm in height.
divergent neck
SHAM COMPARATORGroup B Straumann Tissue Level (TL). Transgingival widening polished collar, 1.8 mm in height.
Interventions
Implants will be placed according to the manufacturer recommendations. Implants will be placed at 1.5 to 2.0 mm from the adjacent natural tooth. However, these distances will be directed by the prosthetic crown needed and they will be recorded in the CRF.
Eligibility Criteria
You may qualify if:
- Male or female ≥18 years old
- Each patient will have one missing tooth in the posterior mandible (positions 4-6). There must be a natural tooth mesially and distally to the implant site. Free end situation are not allowed.
- Adequate bone quality and quantity at the implant site to permit the insertion of a SWEDEN AND MARTINA® Prama Implant in the diameter of 4.25 mm and in the length of 8.5 mm, 10 mm or a Straumann Tissue Level in the diameter of 4.1 mm and in the length of 8 mm or 10mm.
- Opposing dentition must be natural teeth or teeth/implant supported fixed restoration(s).
- Patient has been informed of the follow-up visits and is willing to return to the clinical center for these follow-up visit.
You may not qualify if:
- Medical conditions requiring prolonged use of steroids and/or with medications that can interfere with bone metabolism
- History of leukocyte dysfunction and deficiencies
- History of neoplasic disease requiring the use of radiation or chemotherapy
- Patients with history of renal failure
- Patients with metabolic bone disorders such as osteoporosis
- History of uncontrolled endocrine disorders
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene
- Use of any investigational drug or device within the 30 day period immediately prior to implant surgery on study day 0
- Alcoholism or drug abuse
- History of immunodeficiency syndromes
- Patients who smoke \>20 cigarettes per day or cigar equivalents.
- Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability
- Any bone augmentation on the implant site which was performed in the previous 3 months
- Local inflammation, including untreated periodontitis
- Mucosal diseases such as erosive lichen planus
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PerioCentrum Madrid
Madrid, 28020, Spain
Study Officials
- PRINCIPAL INVESTIGATOR
Fabio Vignoletti, PhD
PerioCentrum Research
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2019
First Posted
March 13, 2020
Study Start
June 17, 2019
Primary Completion
November 17, 2020
Study Completion
March 17, 2021
Last Updated
March 13, 2020
Record last verified: 2020-03