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Completed

NCT Number: NCT03471000

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

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.

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Key information

Conditions

Partial Edentulism Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases Tooth Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Short implants Treatment

Other

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.

Regular implants Treatment

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Jakub Hadzik

Other

Collaborators

  • Dentsply Sirona Implants and Consumables
  • Wroclaw Medical University

Registry information

Official study title

The Influence of the Crown-implant Ratio on the Crestal Bone Level and Implant Secondary Stability - 36 Months Clinical Study

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 20, 2018
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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