Efficacy of Implant Surface Characteristics in Patients With History of Periodontitis

Marginal Bone Loss Clinical Trial

Official title:

Efficacy of Two Dental Implants With Different Surface Characteristics in Patients With History of Periodontitis. A Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05010382
• Other study ID #: 17.516-R_P
• Status: Completed
• Phase: N/A
• Start date: March 13, 2018
• Est. completion date: July 25, 2021

Study information

• Verified date: August 2021
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate in patients with history of periodontitis the clinical, microbiological and radiological outcomes of implants with a modified implant design consisting on a machined surface in the coronal third of the implant. In this 12-month, parallel-arm, randomized controlled trial, patients with history of treated periodontitis and in need of dental implants for single-unit or short edentulous spaces (i.e. two implants) will be randomly assigned to a test group (implants with a hybrid surface, presenting a machined coronal third; HS) or a control group (conventional moderately rough implants; RS). Implants will be restored 3 months later with fixed implant supported reconstructions. Radiological, clinical, microbiological and patient-related outcome measures (PROMs) will be assessed 3, 6 and 12 months after the prosthetic installation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 25, 2021
• Est. primary completion date: July 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

•> 20 years of age

• Presence of =1 adjacent missing teeth, in either maxilla or mandible (up to three missing units).
• A natural tooth had to be present mesially to the most proximal implant site, although free end situations were allowed, and opposing dentition had to be natural teeth or implant supported fixed restorations.
• History of treated and controlled periodontitis.
• Presence of adequate bone volume to achieve primary implant stability without concomitant regeneration

Exclusion Criteria:

• Diseases affecting bone metabolism or wound healing (e.g.)
• History of radiation therapy, leukocyte dysfunction, or any other immunodeficiency
• Drug abuse
• Intrasurgical exclusion criteria, such as the lack of primary stability, the need of bone augmentation or the impossibility of placing the implant based on prosthetic requirements. ?

Related Conditions & MeSH terms

• Marginal Bone Loss
• Periodontitis

Intervention

Procedure:
• Implant placement surgery
Under local anaesthesia, full-thickness mucoperiosteal flaps were elevated, the alveolar ridge measured, and a proper implant dimension (3.75 mm and 4.25 mm diameter; 8 mm, 10 mm and 11.5 mm length) and position selected. After site preparation, each patient was randomly allocated to the test or the control group. Patients in the test group received a modified implant design with the coronal third presenting a machined surface (hybrid surface (HS) group), while in the control group the same implant design with a titanium rough surface up to the implant shoulder was used (rough surface (RS) group). Implants were placed 1 mm sub-crestally. In the case of dehiscence or fenestrations around the implant, the patient was excluded from the study. Once inserted, healing abutments (ranging between 3 -5 mm) were placed, and flaps sutured around the abutments to allow for a transmucosal healing.

Locations

Country	Name	City	State
Spain	Facultad de odontología, Complutense University of Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Ti Care S.L

Country where clinical trial is conducted

Spain, 

References & Publications (19)

Aglietta M, Siciliano VI, Rasperini G, Cafiero C, Lang NP, Salvi GE. A 10-year retrospective analysis of marginal bone-level changes around implants in periodontally healthy and periodontally compromised tobacco smokers. Clin Oral Implants Res. 2011 Jan;22(1):47-53. doi: 10.1111/j.1600-0501.2010.01977.x. Epub 2010 Sep 10. — View Citation

Albouy JP, Abrahamsson I, Berglundh T. Spontaneous progression of experimental peri-implantitis at implants with different surface characteristics: an experimental study in dogs. J Clin Periodontol. 2012 Feb;39(2):182-7. doi: 10.1111/j.1600-051X.2011.01820.x. Epub 2011 Dec 4. — View Citation

Albouy JP, Abrahamsson I, Persson LG, Berglundh T. Implant surface characteristics influence the outcome of treatment of peri-implantitis: an experimental study in dogs. J Clin Periodontol. 2011 Jan;38(1):58-64. doi: 10.1111/j.1600-051X.2010.01631.x. Epub 2010 Nov 24. — View Citation

Albouy JP, Abrahamsson I, Persson LG, Berglundh T. Spontaneous progression of peri-implantitis at different types of implants. An experimental study in dogs. I: clinical and radiographic observations. Clin Oral Implants Res. 2008 Oct;19(10):997-1002. doi: 10.1111/j.1600-0501.2008.01589.x. — View Citation

Buser D, Sennerby L, De Bruyn H. Modern implant dentistry based on osseointegration: 50 years of progress, current trends and open questions. Periodontol 2000. 2017 Feb;73(1):7-21. doi: 10.1111/prd.12185. Review. — View Citation

Cochran DL. A comparison of endosseous dental implant surfaces. J Periodontol. 1999 Dec;70(12):1523-39. — View Citation

Donati M, Ekestubbe A, Lindhe J, Wennström JL. Marginal bone loss at implants with different surface characteristics - A 20-year follow-up of a randomized controlled clinical trial. Clin Oral Implants Res. 2018 May;29(5):480-487. doi: 10.1111/clr.13145. Epub 2018 Mar 23. — View Citation

Esposito M, Murray-Curtis L, Grusovin MG, Coulthard P, Worthington HV. Interventions for replacing missing teeth: different types of dental implants. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003815. Review. Update in: Cochrane Database Syst Rev. 2014;7:CD003815. — View Citation

Gallego L, Sicilia A, Sicilia P, Mallo C, Cuesta S, Sanz M. A retrospective study on the crestal bone loss associated with different implant surfaces in chronic periodontitis patients under maintenance. Clin Oral Implants Res. 2018 Jun;29(6):557-567. doi: 10.1111/clr.13153. Epub 2018 Apr 17. Erratum in: Clin Oral Implants Res. 2020 Oct;31(10):1038. — View Citation

Hinode D, Tanabe S, Yokoyama M, Fujisawa K, Yamauchi E, Miyamoto Y. Influence of smoking on osseointegrated implant failure: a meta-analysis. Clin Oral Implants Res. 2006 Aug;17(4):473-8. Review. — View Citation

John G, Becker J, Schwarz F. Modified implant surface with slower and less initial biofilm formation. Clin Implant Dent Relat Res. 2015 Jun;17(3):461-8. doi: 10.1111/cid.12140. Epub 2013 Aug 27. — View Citation

Karoussis IK, Salvi GE, Heitz-Mayfield LJ, Brägger U, Hämmerle CH, Lang NP. Long-term implant prognosis in patients with and without a history of chronic periodontitis: a 10-year prospective cohort study of the ITI Dental Implant System. Clin Oral Implants Res. 2003 Jun;14(3):329-39. — View Citation

Matarasso S, Rasperini G, Iorio Siciliano V, Salvi GE, Lang NP, Aglietta M. A 10-year retrospective analysis of radiographic bone-level changes of implants supporting single-unit crowns in periodontally compromised vs. periodontally healthy patients. Clin Oral Implants Res. 2010 Sep;21(9):898-903. doi: 10.1111/j.1600-0501.2010.01945.x. Epub 2010 Apr 20. — View Citation

Pikner SS, Gröndahl K, Jemt T, Friberg B. Marginal bone loss at implants: a retrospective, long-term follow-up of turned Brånemark System implants. Clin Implant Dent Relat Res. 2009 Mar;11(1):11-23. doi: 10.1111/j.1708-8208.2008.00092.x. Epub 2008 Apr 1. — View Citation

Polizzi G, Gualini F, Friberg B. A two-center retrospective analysis of long-term clinical and radiologic data of TiUnite and turned implants placed in the same mouth. Int J Prosthodont. 2013 Jul-Aug;26(4):350-8. doi: 10.11607/ijp.3386. — View Citation

Roccuzzo M, Bonino F, Aglietta M, Dalmasso P. Ten-year results of a three arms prospective cohort study on implants in periodontally compromised patients. Part 2: clinical results. Clin Oral Implants Res. 2012 Apr;23(4):389-95. doi: 10.1111/j.1600-0501.2011.02309.x. Epub 2011 Sep 28. — View Citation

Teughels W, Van Assche N, Sliepen I, Quirynen M. Effect of material characteristics and/or surface topography on biofilm development. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:68-81. — View Citation

Wennström JL, Ekestubbe A, Gröndahl K, Karlsson S, Lindhe J. Oral rehabilitation with implant-supported fixed partial dentures in periodontitis-susceptible subjects. A 5-year prospective study. J Clin Periodontol. 2004 Sep;31(9):713-24. — View Citation

Zetterqvist L, Feldman S, Rotter B, Vincenzi G, Wennström JL, Chierico A, Stach RM, Kenealy JN. A prospective, multicenter, randomized-controlled 5-year study of hybrid and fully etched implants for the incidence of peri-implantitis. J Periodontol. 2010 Apr;81(4):493-501. doi: 10.1902/jop.2009.090492. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic marginal bone levels Change	Radiographic marginal bone levels (bone loss) are defined as the distance between the bone crest and the implant shoulder at mesial and distal sites.; For standardization of periapical radiographs the same film holder-beam aiming device will be applied (Rinn System) and silicone custom-made bite blocks will be used to improve reproducible repositioning. All digital radiographs will be evaluated by one calibrated and trained researcher (BS) using a software (AutoCAD® Autodesk ®, California, USA) that allows to calibrate the distances using the known implant length.	Change between baseline and 12 months
Secondary	Clinical periodontal outcome measurements change	Clinical measurements will be performed at six sites per implant of i) probing depth (PD), ii) marginal mucosa recession assessed as length of the implant crown (CLI; distance from the mucosal margin to the oclusal surface at the mid buccal point), iii) bleeding on probing (BoP) and iv) plaque scores (PI). Finally, peri-implant mucositis, defined as the presence of profuse BoP.	Change between baseline and 12 months
Secondary	Microbiologic outcome measurements change	Paper points will be inserted to the depth of the peri-implant pocket and kept in place for 15 sec. The points will be transferred into a screw-capped vial, containing 1.5 ml of reduced transport fluid, (RTF) and maintained at -20ºC. Microbiological analysis by means of anaerobic culture will be performed for the determination of counts, proportion and frequency of detection of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia and Fusobacterium nucleatum.?	Change between baseline and 12 months
Secondary	Patient reported outcome measures (PROM's)change	PROM´s will be assessed by means of a questionnaire comprising 4 items: comfort, appearance, masticatory function and overall satisfaction. Patients will be asked to rate these four aspects according to the following scale: very unsatisfied, unsatisfied, fair, satisfied and very satisfied.	Change between baseline and 12 months