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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04043286
Other study ID # 5190024
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 30, 2019
Est. completion date September 16, 2023

Study information

Verified date April 2024
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this prospective study is to assess the effects of definitive abutment connection at the time of implant placement on bone level changes in the areas of the posterior maxilla and mandible.


Description:

A total of 38 implants will be placed in 19 patients with at least 2 missing posterior teeth in the maxilla and the mandible for this study. Definitive prefabricated abutments will be connected at implant placement. The abutment (control group) on one of the two implants will be randomly selected to go through one complete cycle of complete disconnection and reconnection by hand at 16- (DR1), 19- (DR2), 22- (DR3), and 24- (DR4) weeks after implant surgery. The abutment (test group) on the other implant will be left undisturbed throughout the duration of the study. All implants will remain unrestored within the study period (12 months). Peri-implant bone level changes will be assessed using standardized periapical radiographs immediately after implant placement (T0), at 3-(T3), 6-(T6) and 12-(T12) month follow-up examinations and during each disconnection of the abutments.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date September 16, 2023
Est. primary completion date September 16, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Minimum age 18 - Good oral hygiene - Healed site that possess two or more missing teeth in the maxillary or mandibular posterior region (excluding third molars) - Adequate bone to accommodate at least a 4.3 mm diameter and 8mm length implant at each site - Have at least 8mm interocclusal restorative space - Willing to participate and attend the planned follow-up visits. Exclusion Criteria: - History of alcohol/drug dependency, or any medical, physical, or psychological factor that might affect the surgical or prosthodontic procedures and follow-up examinations - History of radiation therapy to the head and neck region - History or current habit of smoking - History or current habit of bruxism - No opposing occluding dentition or prostheses - Need for bone augmentation during implant placement - Implant insertion torque value <35 Ncm

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Definitive abutment
With two height options available, On1 Base are selected depending on the thickness of the soft tissue. It remains in position from implant placement to finalization, which leaves the soft tissue undisturbed for optimized healing, moved the restorative platform of Nobel Biocare conical connection implants from bone level to tissue level, thereby simplifying the restorative procedures

Locations

Country Name City State
United States Loma Linda University Loma Linda California

Sponsors (2)

Lead Sponsor Collaborator
Loma Linda University Nobel Biocare

Country where clinical trial is conducted

United States, 

References & Publications (26)

Abrahamsson I, Berglundh T, Lindhe J. The mucosal barrier following abutment dis/reconnection. An experimental study in dogs. J Clin Periodontol. 1997 Aug;24(8):568-72. doi: 10.1111/j.1600-051x.1997.tb00230.x. — View Citation

Abrahamsson I, Berglundh T, Wennstrom J, Lindhe J. The peri-implant hard and soft tissues at different implant systems. A comparative study in the dog. Clin Oral Implants Res. 1996 Sep;7(3):212-9. doi: 10.1034/j.1600-0501.1996.070303.x. — View Citation

Alves CC, Munoz F, Cantalapiedra A, Ramos I, Neves M, Blanco J. Marginal bone and soft tissue behavior following platform switching abutment connection/disconnection--a dog model study. Clin Oral Implants Res. 2015 Sep;26(9):983-91. doi: 10.1111/clr.12385. Epub 2014 Apr 16. — View Citation

Becker K, Mihatovic I, Golubovic V, Schwarz F. Impact of abutment material and dis-/re-connection on soft and hard tissue changes at implants with platform-switching. J Clin Periodontol. 2012 Aug;39(8):774-80. doi: 10.1111/j.1600-051X.2012.01911.x. Epub 2012 Jun 7. — View Citation

Berberi AN, Sabbagh JM, Aboushelib MN, Noujeim ZF, Salameh ZA. A 5-year comparison of marginal bone level following immediate loading of single-tooth implants placed in healed alveolar ridges and extraction sockets in the maxilla. Front Physiol. 2014 Jan 31;5:29. doi: 10.3389/fphys.2014.00029. eCollection 2014. — View Citation

Berglundh T, Lindhe J, Ericsson I, Marinello CP, Liljenberg B, Thomsen P. The soft tissue barrier at implants and teeth. Clin Oral Implants Res. 1991 Apr-Jun;2(2):81-90. doi: 10.1034/j.1600-0501.1991.020206.x. — View Citation

Berglundh T, Lindhe J. Dimension of the periimplant mucosa. Biological width revisited. J Clin Periodontol. 1996 Oct;23(10):971-3. doi: 10.1111/j.1600-051x.1996.tb00520.x. — View Citation

Broggini N, McManus LM, Hermann JS, Medina RU, Oates TW, Schenk RK, Buser D, Mellonig JT, Cochran DL. Persistent acute inflammation at the implant-abutment interface. J Dent Res. 2003 Mar;82(3):232-7. doi: 10.1177/154405910308200316. — View Citation

Canullo L, Bignozzi I, Cocchetto R, Cristalli MP, Iannello G. Immediate positioning of a definitive abutment versus repeated abutment replacements in post-extractive implants: 3-year follow-up of a randomised multicentre clinical trial. Eur J Oral Implantol. 2010 Winter;3(4):285-96. — View Citation

Chehroudi B, Gould TR, Brunette DM. The role of connective tissue in inhibiting epithelial downgrowth on titanium-coated percutaneous implants. J Biomed Mater Res. 1992 Apr;26(4):493-515. doi: 10.1002/jbm.820260407. — View Citation

Degidi M, Nardi D, Daprile G, Piattelli A. Nonremoval of immediate abutments in cases involving subcrestally placed postextractive tapered single implants: a randomized controlled clinical study. Clin Implant Dent Relat Res. 2014 Dec;16(6):794-805. doi: 10.1111/cid.12051. Epub 2013 Mar 4. — View Citation

Degidi M, Nardi D, Piattelli A. One abutment at one time: non-removal of an immediate abutment and its effect on bone healing around subcrestal tapered implants. Clin Oral Implants Res. 2011 Nov;22(11):1303-7. doi: 10.1111/j.1600-0501.2010.02111.x. Epub 2011 Feb 24. — View Citation

Ericsson I, Persson LG, Berglundh T, Marinello CP, Lindhe J, Klinge B. Different types of inflammatory reactions in peri-implant soft tissues. J Clin Periodontol. 1995 Mar;22(3):255-61. doi: 10.1111/j.1600-051x.1995.tb00143.x. — View Citation

Grandi T, Guazzi P, Samarani R, Garuti G. Immediate positioning of definitive abutments versus repeated abutment replacements in immediately loaded implants: effects on bone healing at the 1-year follow-up of a multicentre randomised controlled trial. Eur J Oral Implantol. 2012 Spring;5(1):9-16. — View Citation

Grandi T, Guazzi P, Samarani R, Maghaireh H, Grandi G. One abutment-one time versus a provisional abutment in immediately loaded post-extractive single implants: a 1-year follow-up of a multicentre randomised controlled trial. Eur J Oral Implantol. 2014 Summer;7(2):141-9. — View Citation

Iglhaut G, Schwarz F, Winter RR, Mihatovic I, Stimmelmayr M, Schliephake H. Epithelial attachment and downgrowth on dental implant abutments--a comprehensive review. J Esthet Restor Dent. 2014 Sep-Oct;26(5):324-31. doi: 10.1111/jerd.12097. Epub 2014 Mar 11. — View Citation

Koutouzis T, Koutouzis G, Gadalla H, Neiva R. The effect of healing abutment reconnection and disconnection on soft and hard peri-implant tissues: a short-term randomized controlled clinical trial. Int J Oral Maxillofac Implants. 2013 May-Jun;28(3):807-14. doi: 10.11607/jomi.3022. — View Citation

Linkevicius T, Apse P, Grybauskas S, Puisys A. The influence of soft tissue thickness on crestal bone changes around implants: a 1-year prospective controlled clinical trial. Int J Oral Maxillofac Implants. 2009 Jul-Aug;24(4):712-9. — View Citation

Luongo G, Bressan E, Grusovin MG, d'Avenia F, Neumann K, Sbricoli L, Esposito M. Do repeated changes of abutments have any influence on the stability of peri-implant tissues? Four-month post-loading preliminary results from a multicentre randomised controlled trial. Eur J Oral Implantol. 2015 Summer;8(2):129-40. — View Citation

Molina A, Sanz-Sanchez I, Martin C, Blanco J, Sanz M. The effect of one-time abutment placement on interproximal bone levels and peri-implant soft tissues: a prospective randomized clinical trial. Clin Oral Implants Res. 2017 Apr;28(4):443-452. doi: 10.1111/clr.12818. Epub 2016 Mar 25. — View Citation

Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available. — View Citation

Rodriguez X, Vela X, Mendez V, Segala M, Calvo-Guirado JL, Tarnow DP. The effect of abutment dis/reconnections on peri-implant bone resorption: a radiologic study of platform-switched and non-platform-switched implants placed in animals. Clin Oral Implants Res. 2013 Mar;24(3):305-11. doi: 10.1111/j.1600-0501.2011.02317.x. Epub 2011 Oct 3. — View Citation

Rompen E. The impact of the type and configuration of abutments and their (repeated) removal on the attachment level and marginal bone. Eur J Oral Implantol. 2012;5 Suppl:S83-90. Erratum In: Eur J Oral Implantol. 2013 Winter;5(4):379. — View Citation

Smith DE, Zarb GA. Criteria for success of osseointegrated endosseous implants. J Prosthet Dent. 1989 Nov;62(5):567-72. doi: 10.1016/0022-3913(89)90081-4. — View Citation

Squier CA, Collins P. The relationship between soft tissue attachment, epithelial downgrowth and surface porosity. J Periodontal Res. 1981 Jul;16(4):434-40. doi: 10.1111/j.1600-0765.1981.tb00994.x. No abstract available. — View Citation

Wennstrom JL, Bengazi F, Lekholm U. The influence of the masticatory mucosa on the peri-implant soft tissue condition. Clin Oral Implants Res. 1994 Mar;5(1):1-8. doi: 10.1034/j.1600-0501.1994.050101.x. — View Citation

* Note: There are 26 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in bone level between baseline surgery and 12 months Bone level will be measured by periapical radiograph to assess for bone loss after dental implant At baseline (prior to surgical implantation), and 12 months after surgical implantation
Secondary Level of radiolucency after implant A successful implant will be determined by the degree of radiolucency around the implant 12 months after surgery. Radiolucency will be measured by periapical radiograph at baseline prior to surgery and at 12 months after dental implant surgery. Normal degrees of radiolucency are within 2mm at the crestal region and no radiolucency around the body of the implant At baseline (prior to surgical implantation), and 12 months after surgical implantation
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