Efficacy of Implant Surface Characteristics in Patients With History of Periodontitis

NCT05010382 | Completed

• 1 other identifier: 17.516-R_P
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Marginal Bone Loss

Keywords

Implant surface; hybrid; Peri-implantitis; Periodontitis; Marginal bone loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical periodontal outcome measurements change

  Change between baseline and 12 months

• Microbiologic outcome measurements change

  Change between baseline and 12 months

• Patient reported outcome measures (PROM's)change

  Change between baseline and 12 months

Study Arms (2)

Test group

EXPERIMENTAL

Hybrid surface dental implant

Procedure: Implant placement surgery

Control group

EXPERIMENTAL

moderately rough surface implant

Procedure: Implant placement surgery

Interventions

Implant placement surgery PROCEDURE

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.

Control group; Test group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• Diseases affecting bone metabolism or wound healing (e.g.)
• History of radiation therapy, leukocyte dysfunction, or any other immunodeficiency
• Drug abuse

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Ti Care S.L: collaborator

Study Sites (1)

Facultad de odontología, Complutense University of Madrid

Madrid, 28040, Spain

Location

Related Publications (21)

• 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.

  PMID: 28000280 BACKGROUND

• Cochran DL. A comparison of endosseous dental implant surfaces. J Periodontol. 1999 Dec;70(12):1523-39. doi: 10.1902/jop.1999.70.12.1523.

  PMID: 10632528 BACKGROUND

• 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.

  PMID: 23837166 BACKGROUND

• 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.

  PMID: 23981274 BACKGROUND

• 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. doi: 10.1111/j.1600-0501.2006.01353.x.

  PMID: 16968383 BACKGROUND

• 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. doi: 10.1002/14651858.CD003815.pub3.

  PMID: 17943800 BACKGROUND

• 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.

  PMID: 22136592 BACKGROUND

• 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.

  PMID: 18828815 BACKGROUND

• 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.

  PMID: 21092053 BACKGROUND

• Donati M, Ekestubbe A, Lindhe J, Wennstrom 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.

  PMID: 29569767 BACKGROUND

• Wennstrom JL, Ekestubbe A, Grondahl 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. doi: 10.1111/j.1600-051X.2004.00568.x.

  PMID: 15312092 BACKGROUND

• 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.

  PMID: 20831754 BACKGROUND

• 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. doi: 10.1111/j.1600-0501.2005.01244.x.

  PMID: 16907781 BACKGROUND

• 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.

  PMID: 22092445 BACKGROUND

• 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.

  PMID: 20438576 BACKGROUND

• Karoussis IK, Salvi GE, Heitz-Mayfield LJ, Bragger U, Hammerle 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. doi: 10.1034/j.1600-0501.000.00934.x.

  PMID: 12755783 BACKGROUND

• 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.

  PMID: 29664148 BACKGROUND

• Zetterqvist L, Feldman S, Rotter B, Vincenzi G, Wennstrom 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.

  PMID: 20367092 BACKGROUND

• Pikner SS, Grondahl K, Jemt T, Friberg B. Marginal bone loss at implants: a retrospective, long-term follow-up of turned Branemark 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.

  PMID: 18384403 BACKGROUND

• Serrano B, Sanz-Sanchez I, Montero E, Sanz M. Three-Year Outcomes of Dental Implants With a Hybrid Surface Macro-Design Placed in Patients With History of Periodontitis: A Randomised Clinical Trial. J Clin Periodontol. 2025 Jun;52(6):802-812. doi: 10.1111/jcpe.14153. Epub 2025 Apr 25.

  PMID: 40277088 DERIVED

• Serrano B, Sanz-Sanchez I, Serrano K, Montero E, Sanz M. One-year outcomes of dental implants with a hybrid surface macro-design placed in patients with history of periodontitis: A randomized clinical trial. J Clin Periodontol. 2022 Feb;49(2):90-100. doi: 10.1111/jcpe.13575. Epub 2021 Dec 14.

  PMID: 34881442 DERIVED

MeSH Terms

Conditions

Peri-Implantitis; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mariano Sanz Alonso, Chair

  Universidad Complutense de Madrid

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctorate student

Model Details: Patients will recieve an implant with either hybrid surface (test group) or moderately rough surface (control implants

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 18, 2021
• Study Start: March 13, 2018
• Primary Completion: July 25, 2021
• Study Completion: July 25, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)