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The Influence of the Crown-implant Ratio on the Crestal Bone Level and Implant Secondary Stability

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ClinicalTrials.gov Identifier: NCT03471000
Recruitment Status : Completed
First Posted : March 20, 2018
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
Dentsply Sirona Implants
Information provided by (Responsible Party):
Akademicka Poliklinika Stomatologiczna

Brief Summary:
The aim of the study was to determine whether implant length and the crown-to-implant (C/I) ratio influence implant stability and the loss of the surrounding marginal bone, and whether short implants can be used instead of sinus augmentation procedures.

Condition or disease Intervention/treatment Phase
Partial Edentulism Tooth Loss Other: Short implants Treatment Other: Regular implants Treatment Not Applicable

Detailed Description:

The patients participating in the study (n=30) had one single tooth implant - a short (OsseoSpeed™ L6Ø4 mm, Implants) or a regular implant (OsseoSpeed™ L11 and L13Ø4 mm, DENTSPLY Implants) - placed in the maxilla. The evaluation was based on clinical and radiological examination.

The crown-to-implant ratio was determined by dividing the length of the crown together with the abutment by the length of the implant placed crestally. Mean crown-to-implant ratios were calculated separately for each group and its correlation with the MBL (marginal bone loss) and stability was assessed. The authors compared the correlation between the C/I ratio values, MBL and secondary implant stability.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Influence of the Crown-implant Ratio on the Crestal Bone Level and Implant Secondary Stability - 36 Months Clinical Study
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : January 1, 2016
Actual Study Completion Date : January 1, 2016

Arm Intervention/treatment
Experimental: Short implants Treatment
Group 2 (G2; n=15 patients) had short implants (OsseoSpeed ™ L6mm Ø4 mm) [DENTSPLY Implants, Waltham, MA, USA] placed without sinus lift and augmentation procedure.
Other: Short implants Treatment
Short implants are placed in the alveolar bone and a clinical Ostell and Periotest evaluation of the implants after a period of time is done. Analysis of periapical radiographs and CBCT images after a period of time. Bone around the implant was measured, marginal bone level loss is determined.

Active Comparator: Regular Implants Treatment
Group 1 (G1; n=15 patients) had conventional dental implants (OsseoSpeed ™ L11 Ø4 mm and L13 Ø4 mm) [DENTSPLY Implants, Waltham, MA, USA] placed, preceded by the sinus lift procedure from a lateral window approach with the application of the xenogeneic bone graft Geistlich Bio-Oss® [Geistlich AG, Wolhusen, Switzerland]. The lateral window approach sinus lift surgery was performed 6 weeks prior to the implant placement by the same surgeon.
Other: Regular implants Treatment
Sinus lift procedure is done and regular implants are placed in the alveolar bone and a clinical Ostell and Periotest evaluation of the implants after a period of time is done. Analysis of periapical radiographs and CBCT images after a period of time. Bone around the implant was measured, marginal bone level loss is determined.




Primary Outcome Measures :
  1. Clinical measurement of implant stability [ Time Frame: 36 months ]
    Evaluation of implant secondary stability in both groups. Stability measured and evaluated with Periotest(R) device - after 36 months.


Secondary Outcome Measures :
  1. Radiological measurement of marginal bone loss around implant [ Time Frame: 36 months ]
    Evalation if there is difference in marginal bone level around the implants in both groups. Periapical radiographs and CBCT images taken and the begining and at the end of the observation period will be compared and bone level will be measured. Loss of marginal bone will be calculated.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-smoking patients with no systemic or local diseases were qualified.

Additional inclusion criteria were as follows:

  • minimal apicocoronal height of the alveolar ridge of 6 mm in the region of the implant insertion in the pre-surgical qualification
  • minimal width of the alveolar ridge of 6-7 mm in the region of interest
  • HKT (height of the keratinized tissue) higher than 2 mm
  • API ≤ 35 (Approximal Plaque Index)
  • PI ≤ 25. (Plaque Index)
  • Bone Type III or D2 were included in the study
  • No graft procedures in the area of interest,

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471000


Sponsors and Collaborators
Akademicka Poliklinika Stomatologiczna
Dentsply Sirona Implants
Investigators
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Principal Investigator: Marzena Dominiak, Prof Medical University Wrocław

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Akademicka Poliklinika Stomatologiczna
ClinicalTrials.gov Identifier: NCT03471000     History of Changes
Other Study ID Numbers: AkademickaPS
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Akademicka Poliklinika Stomatologiczna:
implant
dental implant

Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases