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

Tooth Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03471000
• Other study ID #: crown-implant ratio
• Status: Completed
• Phase: N/A
• Start date: January 1, 2012
• Est. completion date: January 1, 2016

Study information

• Verified date: January 2020
• Source: Akademicka Poliklinika Stomatologiczna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 1, 2016
• Est. primary completion date: January 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Partial Edentulism
• Tooth Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Jakub Hadzik	Dentsply Sirona Implants, Wroclaw Medical University

References & Publications (1)

Hadzik J, Krawiec M, Slawecki K, Kunert-Keil C, Dominiak M, Gedrange T. The Influence of the Crown-Implant Ratio on the Crestal Bone Level and Implant Secondary Stability: 36-Month Clinical Study. Biomed Res Int. 2018 May 16;2018:4246874. doi: 10.1155/201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical measurement of implant stability	Evaluation of implant secondary stability in both groups. Stability measured and evaluated with Periotest(R) device - after 36 months.	36 months
Secondary	Radiological measurement of marginal bone loss around implant	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.	36 months