Submerged vs. Nonsubmerged Single Laser-microgrooved Dental Implants.
Primary Purpose
Partially Edentulous Maxilla, Mandible
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Microgrooved dental implants
Sponsored by
About this trial
This is an interventional treatment trial for Partially Edentulous Maxilla, Mandible focused on measuring submerged two-stage, nonsubmerged one-stage, dental implants, marginal bone loss
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria were: age ≥ 18 years, good general health, without contraindications to implant surgery, presence of at least two non-adjacent edentulous sites requiring implant therapy. Each implant site had to be located in the left or right hemi-posterior mandible or in the left or right hemi- posterior maxilla.
-
Exclusion Criteria:
- Exclusion criteria were: implants placed into regenerated bone, 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%, periodontally compromised patients (with attachment loss of 3 mm and/or radiographic bone loss of 30% of root length in 30% of sites), teeth adjacent to the implant area (mesial and distal) affected by untreated periodontal and/or endodontic infections.
Sites / Locations
- Universita la Sapienza
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
dental implants
dentale implants
Arm Description
microgrooved dental implants submerged
microgrooved dental implants nonsubmerged
Outcomes
Primary Outcome Measures
radiographic marginal bone loss
Secondary Outcome Measures
Full Information
NCT ID
NCT03674762
First Posted
September 14, 2018
Last Updated
September 14, 2018
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT03674762
Brief Title
Submerged vs. Nonsubmerged Single Laser-microgrooved Dental Implants.
Official Title
Submerged vs. Nonsubmerged Single Laser-microgrooved Implants. Clinical and Radiographic Results at 3-years of RCT With Split Mouth Design.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 14, 2018 (Actual)
Primary Completion Date
September 14, 2018 (Actual)
Study Completion Date
September 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim: to evaluate and compare radiographic marginal bone loss (MBL) and soft tissue parameters around submerged/two-stage and nonsubmerged/one-stage single implants with same tapered body design and surface, same thread design and distance, and same collar surface (laser-microgrooved), after 3 years of loading.
Detailed Description
Materials and methods: 20 submerged/two-stage implants and 20 nonsubmerged/one stage implants were placed randomly with a split mouth design, in 20 partially edentulous patients. Radiographic and clinical examinations were carried out at the implant placement (Baseline, BSL), at the delivery of prosthetic restorations (T0), and at each year of the follow-up period (T1, T2, T3). Plaque index (PI), probing depth (PD), bleeding on probing (BOP), and gingival recession (REC) were recorded. Radiographic marginal bone levels (MBL) were assessed at the mesial (MI) and distal (DI) aspect of implant sites. In addition, the influence of keratinized tissue thickness (KTT) on MBL was investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partially Edentulous Maxilla, Mandible
Keywords
submerged two-stage, nonsubmerged one-stage, dental implants, marginal bone loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
The cases were randomly divided into two groups as two-stage/submerged, and one-stage/nonsubmerged. Thus, in each patient, the two implants (submerged and nonsubmerged) were placed randomly in the left and right hemi-mandible or in the left and right hemi-maxilla
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dental implants
Arm Type
Experimental
Arm Description
microgrooved dental implants submerged
Arm Title
dentale implants
Arm Type
Experimental
Arm Description
microgrooved dental implants nonsubmerged
Intervention Type
Device
Intervention Name(s)
Microgrooved dental implants
Intervention Description
Dental Implant placement
Primary Outcome Measure Information:
Title
radiographic marginal bone loss
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria were: age ≥ 18 years, good general health, without contraindications to implant surgery, presence of at least two non-adjacent edentulous sites requiring implant therapy. Each implant site had to be located in the left or right hemi-posterior mandible or in the left or right hemi- posterior maxilla.
-
Exclusion Criteria:
Exclusion criteria were: implants placed into regenerated bone, 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%, periodontally compromised patients (with attachment loss of 3 mm and/or radiographic bone loss of 30% of root length in 30% of sites), teeth adjacent to the implant area (mesial and distal) affected by untreated periodontal and/or endodontic infections.
Facility Information:
Facility Name
Universita la Sapienza
City
Roma
ZIP/Postal Code
00100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
Esposito M, Coulthard P, Thomsen P, Worthington HV. Interventions for replacing missing teeth: different types of dental implants. Cochrane Database Syst Rev. 2005; 1:CD003815 Brånemark PI, Hansson BO, Adell R, Breine U, Lindström J, Hallén O, et al. (1977) Osseointegrated implants in the treatment of the edentulous jaw. Scandinavian Journal of Pasticic and Reconstructive Surgery; 16: 1-99. . Akcali A, Trullenque-Eriksson A, Sun C, Petrie A, Nibali L, & Donos N. (2017) What is the effect of soft tissue thickness on crestal bone loss around dental implants? A systematic review. Clinical Oral Implant Research; 28, 1045-1053. Becktor JP, Isaksson S, Billström C. (2007) A prospective multicenter study using two different surgical approaches in the mandible with turned Brånemark implants: Conventional loading using fixed prostheses. Clinical Implant Dentistry and Related Research ;9:179-185. Berglundh T, Abrahamsson I,Welander M, Lang NP, Lindhe J. (2007) Morphogenesis of the peri-implant mucosa: An experimental study in dogs. Clinical Oral Implant Research; 18:1-8. Broggini N, McManus LM, Hermann JS, Medina RU, Oates TW, Schenk RK, et al. (2003). Persistent acute inflammation at the implant-abutment interface. Journal of Dental Research 82:232-237. Buser D, Mericske-Stern R, Bernard JP, et al. (1997) Long-term evaluation of non-submerged ITI implants. Part 1: 8-year life table analysis of a prospective multi-center study with 2359 implants. Clinical Oral Implants Research; 8:161-172. Cecchinato D, Olsson C, Lindhe J. (2004) Submerged or non-submerged healing of endosseous implants to be used in the rehabilitation of partially dentate patients. Journal of Clinical Periodontoly ;31:299-308. Cordaro L, Torsello F, Roccuzzo M (2009). Clinical outcome of submerged vs. non-submerged implants placed in fresh extraction sockets. Clinical Oral Implants Research ;20:1307-1313. Esposito M, Coulthard P, Thomsen P, Worthington HV. (2005) Interventions for replacing missing teeth: different types of dental implants. The Cochrane Database of Systematic Reviews; 1:CD003815 Esposito M, Grusovin MG, Chew YS, Coulthard P, Worthington HV. (2009) One-stage versus two-stage implant placement. A Cochrane systematic review of randomised controlled clinical trials. European Journal of Oral Implantology. Summer;2(2):91-9. Hermann, J.S., Cochran, D.L., Nummikoski, P.V. & Buser, D. (1997) Crestal bone changes around titanium implants. A radiographic evaluation of unloaded non-submerged and submerged implants in the canine mandible. Journal of Periodontology 68: 1117-1130. Jansen, V.K., Conrads, G. & Richter, E.-J. (1997) Microbial leakage and marginal fit of the implant-abutment interface. International Journal of Oral and Maxillofacial Implants 12: 527-540 Jung RE, Jones AA, Higginbottom FL, Wilson TG, Schoolfield J, Buser D, Hämmerle CH, Cochran DL (2008) The influence of nonmatching implant and abutment diameters on radiographic crestal bone levels in dogs. Journal of Periodontology. Feb;79(2):260-70. Linkevicius T, Apse P, Grybauskas S, & Puisys A. (2009) The influence of soft tissue thickness on crestal bone changes around implants: A 1-year prospective controlled clinical trial. International Journal of Oral & Maxillofacial Implant; 24, 712-719. Linkevicius T, Apse, P, Grybauskas S, & Puisys A. (2010) Influence of thin mucosal tissues on crestal bone stability around implants with platform switching: A 1-year pilot study. Journal of Oral & Maxillofacial Surgery; 68, 2272-2277.
Results Reference
background
PubMed Identifier
31848762
Citation
Guarnieri R, Di Nardo D, Di Giorgio G, Miccoli G, Testarelli L. Clinical and radiographics results at 3 years of RCT with split-mouth design of submerged vs. nonsubmerged single laser-microgrooved implants in posterior areas. Int J Implant Dent. 2019 Dec 18;5(1):44. doi: 10.1186/s40729-019-0196-0.
Results Reference
derived
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Submerged vs. Nonsubmerged Single Laser-microgrooved Dental Implants.
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