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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03686865
Other study ID # 4597 bis
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 18, 2018
Est. completion date September 18, 2018

Study information

Verified date September 2018
Source University of Roma La Sapienza
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of present study was to compare peri-implant marginal bone loss and soft tissues conditions around single Laser-Lok implants placed in alveolar


Description:

Records of 20 consecutive patients treated with dental implants placed in post-extraction sockets augmented with porcine derived bone and 20 consecutive patients with implants placed in native bone were reviewed. For each implant, the radio- graphs from the surgical appointment were compared to those from the last follow-up visit and evaluated regarding changes of marginal bone level over time.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 18, 2018
Est. primary completion date September 18, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- mono-edentulism, age = 18 years, good general health, without contraindications to implant surgery

Exclusion Criteria:

- lack of a periodontal chart and periapical radiograph at the beginning and at the end of follow-up period, alcohol and drug abuse, pregnancy, or uncontrolled metabolic disorders, tobacco smoking (> 10 cigarettes/day), full mouth plaque score (FMPS), and full mouth bleeding score /FMBS) =25%, teeth adjacent to the implant area (mesial and distal) affected by untreated periodontal and/or endodontic infections.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
dental implants
extraction sockets regenerated with xenograft

Locations

Country Name City State
Italy Universita la Sapienza Roma

Sponsors (1)

Lead Sponsor Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (1)

1. Carlsson GE, Bergman B, Hedega °rd B. Changes in contour of the maxillary alveolar process under im- mediate dentures. A longitudinal clinical and x-ray cephalometric study covering 5 years. Acta Odontol Scand 1967;25:45-75. 2. Arau ´jo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol 2005;32:212-218. 3. Pietrokovski J, Massler M. Alveolar ridge resorption following tooth extraction. J Prosthet Dent 1967;17: 21-27. 4. Johnson K. A study of the dimensional changes occurring in the maxilla following tooth extraction. Aust Dent J 1969;14:241-244. 5. Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: A clinical and radiographic 12- month prospective study. Int J Periodontics Restor- ative Dent 2003;23:313-323. 6. Arau ´jo MG, Carmagnola D, Berglundh T, Thilander B, Lindhe J. Orthodontic movement in bone defects augmented with Bio-Oss. An experimental study in dogs. J Clin Periodontol 2001;28:73-80. 7. Carmagnola D, Berglundh T, Lindhe J. The effect of a fibrin glue on the integration of Bio-Oss with bone tissue. An experimental study in Labrador dogs. J Clin Periodontol 2002;29:377-383. 8. Cardaropoli G, Arau ´jo M, Hayacibara R, Sukekava F, Lindhe J. Healing of extraction sockets and surgically produced - augmented and non-augmented - defects in the alveolar ridge. An experimental study in the dog. J Clin Periodontol 2005;32:435-440. 9. Becker W, Clokie C, Sennerby L, Urist MR, Becker BE. Histologic findings after implantation and evaluation of different grafting materials and titanium micro screws into extraction sockets: Case reports. J Periodontol 1998;69:414-421. 10. Artzi Z, Tal H, Dayan D. Porous bovine bone mineral in healing of human extraction sockets. Part 1: Histo- morphometric evaluations at 9 months. J Periodontol 2000;71:1015-1023. 11. Artzi Z, Tal H, Dayan D. Porous bovine bone mineral in healing of human extraction sockets: 2. Histochemical observations at 9 months. J Periodontol 2001;72:152- 159. 12. Iasella JM, Greenwell H, Miller RL, et al. Ridge preservation with freeze-dried bone allograft and a col- lagen membrane compared to extraction alone for implant site development: A clinical and histologic study in humans. J Periodontol 2003;74:990-999. 13. Carmagnola D, Adriaens P, Berglundh T. Healing of human extraction sockets filled with Bio-Oss. Clin Oral Implants Res 2003;14:137-143. 14. Becker W, Urist M, Becker BE, et al. Clinical and histologic observations of sites implanted with intrao- ral autologous bone grafts or allografts. 15 human case reports. J Periodontol 1996;67:1025-1033. 15. Froum S, Cho SC, Rosenberg E, Rohrer M, Tarnow D. Histological comparison of healing extraction sockets implanted with bioactive glass or demineralized freeze-dried bone allograft: A pilot study. J Periodontol 2002;73:94-102. 16. Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: A clinical and histomorphometric study. J Periodontol 2008;79:1370-1377. 17. Lekovic V, Kenney EB, Weinlaender M, et al. A bone regenerative approach to alveolar ridge maintenance following tooth extraction. Report of 10 cases. J Periodontol 1997;68:563-570. 18. Lekovic V, Camargo PM, Klokkevold PR, et al. Pres- ervation of alveolar bone in extraction sockets using bioabsorbable membranes. J Periodontol 1998;69: 1044-1049. 19. Nevins M, Camelo M, De Paoli S, et al. A study of the fate of the buccal wall of extraction sockets of teeth with prominent roots. Int J Periodontics Restorative Dent 2006;26:19-29. 20. Albrektsson T, Bra ° nemark PI, Hansson HA, Lindstro ¨ m J. Osseointegrated titanium implants. Requirements for ensuring a long-lasting, direct bone-to-implant anchorage in man. Acta Orthop Scand 198

Outcome

Type Measure Description Time frame Safety issue
Primary peri-implant marginal bone loss 2 years
Secondary peri-implant soft tissue conditions 2 years