Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm)

Bone Loss, Alveolar Clinical Trial

Official title:

Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm) in Combination With Sinus Floor Elevation: A Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04144322
• Other study ID #: HUM00151047
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the survival rate of 5 mm short implants compared to longer implants (10 mm) placed in sinus-grafted sites.

Primary aim: Compare bone loss between the two groups Secondary aim: Compare surgical time and patient-reported outcomes (satisfaction and post-operative pain)

Description:

34 patients requiring an implant to replace an upper missing tooth in the premolar or 1st molar area with a bone crest height from 5 to 8 mm will be recruited for this trial. Patients will be randomized to either the test (5-mm implant) or control group (10-mm implant) using a computer-generated randomization list . 17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant while the other 17 patients will receive a 5 mm short implant.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: September 30, 2024
• Est. primary completion date: April 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 20-70 years at enrollment

• Systemically healthy patients

• Full-mouth plaque score and full-mouth bleeding score = 30% (measured at four sites per tooth)

• In need of one premolar or 1st molar dental implant in the maxillary area

• Neighboring teeth to the planned implant must have natural root(s) or implant supported restoration.

• Presence of natural tooth/teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crown/s deemed by the investigator as likely to present an initially stable implant situation

• Residual bone height under the maxillary sinus between 5 to 7 mm and a width of at least 7 mm, as measured on cone beam computer tomography (CBCT) scans.

Exclusion Criteria:

• Unlikely to be able to comply with study procedures

• Uncontrolled pathologic processes in the oral cavity

• History of head and neck chemotherapy within 5 years prior to surgery

• Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration

• Uncontrolled diabetes mellitus HbA1c >8

• Taking corticosteroids, IV bisphosphonates, or any other medication that could influence post-operative healing and/or osseointegration

• Smokes more than 10 cigarettes/day

• Bruxer

• Present alcohol and/or drug abuser

• Pregnant, unsure pregnancy status, or lactating females (self-reported)

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone Loss, Alveolar

Intervention

Device:
• Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition
Placement of a short implant
• Zimmer T3 with DCD Ex Hex Parallel Walled implants
Placement of a long implant with sinus lift and bone graft

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (13)

Anitua E, Alkhraist MH, Pinas L, Begona L, Orive G. Implant survival and crestal bone loss around extra-short implants supporting a fixed denture: the effect of crown height space, crown-to-implant ratio, and offset placement of the prosthesis. Int J Oral Maxillofac Implants. 2014 May-Jun;29(3):682-9. doi: 10.11607/jomi.3404. — View Citation

Anitua E, Pinas L, Orive G. Retrospective study of short and extra-short implants placed in posterior regions: influence of crown-to-implant ratio on marginal bone loss. Clin Implant Dent Relat Res. 2015 Feb;17(1):102-10. doi: 10.1111/cid.12073. Epub 2013 May 8. — View Citation

Buser D, Janner SF, Wittneben JG, Bragger U, Ramseier CA, Salvi GE. 10-year survival and success rates of 511 titanium implants with a sandblasted and acid-etched surface: a retrospective study in 303 partially edentulous patients. Clin Implant Dent Relat Res. 2012 Dec;14(6):839-51. doi: 10.1111/j.1708-8208.2012.00456.x. — View Citation

Chappuis V, Araujo MG, Buser D. Clinical relevance of dimensional bone and soft tissue alterations post-extraction in esthetic sites. Periodontol 2000. 2017 Feb;73(1):73-83. doi: 10.1111/prd.12167. — View Citation

Fan T, Li Y, Deng WW, Wu T, Zhang W. Short Implants (5 to 8 mm) Versus Longer Implants (>8 mm) with Sinus Lifting in Atrophic Posterior Maxilla: A Meta-Analysis of RCTs. Clin Implant Dent Relat Res. 2017 Feb;19(1):207-215. doi: 10.1111/cid.12432. Epub 2016 Jun 13. — View Citation

Garaicoa-Pazmino C, Suarez-Lopez del Amo F, Monje A, Catena A, Ortega-Oller I, Galindo-Moreno P, Wang HL. Influence of crown/implant ratio on marginal bone loss: a systematic review. J Periodontol. 2014 Sep;85(9):1214-21. doi: 10.1902/jop.2014.130615. Epub 2014 Jan 20. — View Citation

Lemos CA, Ferro-Alves ML, Okamoto R, Mendonca MR, Pellizzer EP. Short dental implants versus standard dental implants placed in the posterior jaws: A systematic review and meta-analysis. J Dent. 2016 Apr;47:8-17. doi: 10.1016/j.jdent.2016.01.005. Epub 2016 Jan 19. — View Citation

Pieri F, Forlivesi C, Caselli E, Corinaldesi G. Short implants (6mm) vs. vertical bone augmentation and standard-length implants (>/=9mm) in atrophic posterior mandibles: a 5-year retrospective study. Int J Oral Maxillofac Surg. 2017 Dec;46(12):1607-1614. doi: 10.1016/j.ijom.2017.07.005. Epub 2017 Jul 24. — View Citation

Sargozaie N, Moeintaghavi A, Shojaie H. Comparing the Quality of Life of Patients Requesting Dental Implants Before and After Implant. Open Dent J. 2017 Aug 31;11:485-491. doi: 10.2174/1874210601711010485. eCollection 2017. — View Citation

Schneider CA, Rasband WS, Eliceiri KW. NIH Image to ImageJ: 25 years of image analysis. Nat Methods. 2012 Jul;9(7):671-5. doi: 10.1038/nmeth.2089. — View Citation

Strietzel FP, Reichart PA. Oral rehabilitation using Camlog screw-cylinder implants with a particle-blasted and acid-etched microstructured surface. Results from a prospective study with special consideration of short implants. Clin Oral Implants Res. 2007 Oct;18(5):591-600. doi: 10.1111/j.1600-0501.2007.01375.x. Epub 2007 Jun 21. — View Citation

Telleman G, Raghoebar GM, Vissink A, Meijer HJ. Impact of platform switching on peri-implant bone remodeling around short implants in the posterior region, 1-year results from a split-mouth clinical trial. Clin Implant Dent Relat Res. 2014 Feb;16(1):70-80. doi: 10.1111/j.1708-8208.2012.00461.x. Epub 2012 May 11. — View Citation

Thoma DS, Haas R, Sporniak-Tutak K, Garcia A, Taylor TD, Hammerle CHF. Randomized controlled multicentre study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures: 5-Year data. J Clin Periodontol. 2018 Dec;45(12):1465-1474. doi: 10.1111/jcpe.13025. Epub 2018 Nov 25. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mesial-distal (M-D) bone loss	Comparing mesial-distal (M-D) bone loss between the two groups. This will be measured in millimeters using standardized radiographs of the implant site at the screening visit, surgical visit, 4 months post-op, 5 months post-op, 12 months post-op, and 24 months post-op visits.	Baseline, surgical visit 1 day, 4 months, 5 months, 12 months, 24 months
Secondary	Survival rate	The survival rate of the two groups will be recorded as a percentage at the 5 month post-op, 12 month post-op, and 24 month post-op visits based on clinician assessment.	5 month post-op, 12 month post-op, and 24 month post-op visits
Secondary	Number of sites with bleeding on probing	The number of sites with bleeding on probing will be compared between the two groups. Bleeding on probing of the implant site will be measured with a periodontal probe at the 5 month post-op, 12 month post-op, and 24 month post-op visits.	5 month post-op, 12 month post-op, and 24 month post-op visits
Secondary	Probing pocket depth	The probing pocket depths will be compared between the two groups. Probing depths of the implant site will be measured with a periodontal probe at the 5 month post-op, 12 month post-op, and 24 month post-op visits.	5 month post-op, 12 month post-op, and 24 month post-op visits