The Effects of Dis/Reconnection of Implant Abutments on Peri-implant Bone Levels

Bone Loss Clinical Trial

Official title:

The Effects of Disconnection and Reconnection of Implant Abutments on Peri-implant Bone Levels: a 1-year Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043286
• Other study ID #: 5190024
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Bone Loss
• Gingival Recession
• Gum Recession

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)

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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

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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

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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

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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

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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

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* Note: There are 26 references in all — Click 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