Soft Peri-implant Tissue Around Different Abutment Materials

NCT03459547 | Unknown DMC

• 1 other identifier: 0000102
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Soft tissue attachment to the implant surface serves as a biological seal preventing the development of inflammatory periimplant diseases (i.e. peri-implant mucositis and peri-implantitis).It occurs in the presence of a biomaterial during healing of the surgical wound that might be influence by this foreign body. Myofibroblasts represent key players in the physiological reconstruction of connective tissue after injury. This work will focus on the role of myofibroblasts during the early phases of the healing process in peri-implant tissues around four different abutment materials.

Conditions

Dental Implant Failure Nos; Wound Heal

Outcome Measures

Primary Outcomes (1)

• Early healing of peri-implant soft tissues

  The early healing of soft peri-implant tissues will be interpreted through the activity of myofybroblasts

  24 hours

Study Arms (4)

dental implant + PEEK (test)

EXPERIMENTAL

Dental implant insertion, material polyetheretherketone

Device: dental implant

dental implant + Ti-5 (control)

ACTIVE COMPARATOR

Dental implant insertion, material titanium group 5

Device: dental implant

dental implant + zirconia (control)

ACTIVE COMPARATOR

dental implant insertion, material zirconia

Device: dental implant

dental implant + Ti-4 (control)

ACTIVE COMPARATOR

dental implant insertion, material titanium group 4

Device: dental implant

Interventions

dental implant DEVICE

Local anesthesia, flap preparation, dental implant insertion, flap suture, healing abutment insertion. Peri-implant soft tissue samples taken prior to implant placement and 24 hours after.

Also known as: PEEK, Ti-4, Ti-5, zirconia

dental implant + PEEK (test); dental implant + Ti-4 (control); dental implant + Ti-5 (control); dental implant + zirconia (control)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Absence of Systemic Diseases / Disorders
• Smoking ≤ 5 cigarettes per day
• Periodontally healthy or treated
• Full-mouth plaque score (FMPS) ≤ 15% at baseline
• Full-mouth bleeding score (FMBS) ≤ 15% at baseline
• Presence of edentulous space needing an all on four or all on six treatment with overdenture
• Width of the keratinized gingiva ≥ 2 at the level of the crest

You may not qualify if:

• (I) • Pregnancy / lactation
• Use of systemic antibiotics in the last 3 months
• Use of systemic antibiotics as prophylaxis for endocarditis
• A chronically treated patient (i.e. 2 weeks or longer) with medicines known to affect periodontal tissues (e.g. phenytoin, calcium antagonists, cyclosporine, warfarin and non-steroidal anti-inflammatory drugs) the last month before starting the study
• Radiotherapy in the neck-head region
• HIV, TB, hepatitis or other infectious diseases
• Abuse with drugs or alcohol
• Smoked cigarettes\> 5 cigarettes per day
• Untreated periodontitis
• FMPS\> 15% at baseline
• FMBS\> 15% at baseline
• Implants with peri-implant history
• Width of keratinized tissue over crest \<2 mm
• Need for bone reconstruction around implants to be inserted

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Max-Planck Institute of Molecular Cell Biology and Genetics: collaborator

Study Sites (1)

Department of Oral and Maxillofacial Sciences. Section of Periodontics.Sapienza, University of Rome

Rome, 00161, Italy

RECRUITING

Related Publications (18)

• Lindhe J, Wennstrom JL & Berglundh T. The mucosa at teeth and implants. In: Lindhe, J., Lang, N. P. & Karring, T. (eds). Clinical Periodontology and Implant Dentistry, 5th edition, pp. 69-85, 2008.

  BACKGROUND

• Small PN, Tarnow DP. Gingival recession around implants: a 1-year longitudinal prospective study. Int J Oral Maxillofac Implants. 2000 Jul-Aug;15(4):527-32.

  PMID: 10960986 BACKGROUND

• Apse P, Zarb GA, Schmitt A, Lewis DW. The longitudinal effectiveness of osseointegrated dental implants. The Toronto Study: peri-implant mucosal response. Int J Periodontics Restorative Dent. 1991;11(2):94-111. No abstract available.

  PMID: 1718917 BACKGROUND

• Rodriguez X, Navajas A, Vela X, Fortuno A, Jimenez J, Nevins M. Arrangement of Peri-implant Connective Tissue Fibers Around Platform-Switching Implants with Conical Abutments and Its Relationship to the Underlying Bone: A Human Histologic Study. Int J Periodontics Restorative Dent. 2016 Jul-Aug;36(4):533-40. doi: 10.11607/prd.2580.

  PMID: 27333011 BACKGROUND

• Cocchetto R, Canullo L. The "hybrid abutment": a new design for implant cemented restorations in the esthetic zones. Int J Esthet Dent. 2015 Summer;10(2):186-208.

  PMID: 25874269 BACKGROUND

• Braun E, Iacono VJ. Tapered tips to think about. Int J Periodontics Restorative Dent. 2006 Feb;26(1):7. No abstract available.

  PMID: 16515091 BACKGROUND

• Urdaneta RA, Leary J, Lubelski W, Emanuel KM, Chuang SK. The effect of implant size 5 x 8 mm on crestal bone levels around single-tooth implants. J Periodontol. 2012 Oct;83(10):1235-44. doi: 10.1902/jop.2012.110299. Epub 2012 Feb 6.

  PMID: 22309172 BACKGROUND

• Schwarz F, Mihatovic I, Becker J, Bormann KH, Keeve PL, Friedmann A. Histological evaluation of different abutments in the posterior maxilla and mandible: an experimental study in humans. J Clin Periodontol. 2013 Aug;40(8):807-15. doi: 10.1111/jcpe.12115. Epub 2013 Jun 3.

  PMID: 23725491 BACKGROUND

• Waerhaug J. Subgingival plaque and loss of attachment in periodontosis as evaluated on extracted teeth. J Periodontol. 1977 Mar;48(3):125-30. doi: 10.1902/jop.1977.48.3.125.

  PMID: 264960 BACKGROUND

• Welander M, Abrahamsson I, Berglundh T. The mucosal barrier at implant abutments of different materials. Clin Oral Implants Res. 2008 Jul;19(7):635-41. doi: 10.1111/j.1600-0501.2008.01543.x. Epub 2008 May 19.

  PMID: 18492075 BACKGROUND

• Rompen E, Domken O, Degidi M, Pontes AE, Piattelli A. The effect of material characteristics, of surface topography and of implant components and connections on soft tissue integration: a literature review. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:55-67. doi: 10.1111/j.1600-0501.2006.01367.x. No abstract available.

  PMID: 16968382 BACKGROUND

• Sanz-Martin I, Sanz-Sanchez I, Carrillo de Albornoz A, Figuero E, Sanz M. Effects of modified abutment characteristics on peri-implant soft tissue health: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Jan;29(1):118-129. doi: 10.1111/clr.13097. Epub 2017 Oct 26.

  PMID: 29072346 BACKGROUND

• Garcia B, Camacho F, Penarrocha D, Tallarico M, Perez S, Canullo L. Influence of plasma cleaning procedure on the interaction between soft tissue and abutments: a randomized controlled histologic study. Clin Oral Implants Res. 2017 Oct;28(10):1269-1277. doi: 10.1111/clr.12953. Epub 2016 Aug 23.

  PMID: 27552929 BACKGROUND

• Tomasi C, Tessarolo F, Caola I, Wennstrom J, Nollo G, Berglundh T. Morphogenesis of peri-implant mucosa revisited: an experimental study in humans. Clin Oral Implants Res. 2014 Sep;25(9):997-1003. doi: 10.1111/clr.12223. Epub 2013 Jun 26.

  PMID: 23799997 BACKGROUND

• Linkevicius T, Vaitelis J. The effect of zirconia or titanium as abutment material on soft peri-implant tissues: a systematic review and meta-analysis. Clin Oral Implants Res. 2015 Sep;26 Suppl 11:139-47. doi: 10.1111/clr.12631. Epub 2015 Jun 13.

  PMID: 26073346 BACKGROUND

• Sailer I, Philipp A, Zembic A, Pjetursson BE, Hammerle CH, Zwahlen M. A systematic review of the performance of ceramic and metal implant abutments supporting fixed implant reconstructions. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:4-31. doi: 10.1111/j.1600-0501.2009.01787.x.

  PMID: 19663946 BACKGROUND

• Neumann EA, Villar CC, Franca FM. Fracture resistance of abutment screws made of titanium, polyetheretherketone, and carbon fiber-reinforced polyetheretherketone. Braz Oral Res. 2014;28:S1806-83242014000100239. doi: 10.1590/1807-3107bor-2014.vol28.0028. Epub 2014 Aug 4.

  PMID: 25098826 BACKGROUND

• Steinberg EL, Rath E, Shlaifer A, Chechik O, Maman E, Salai M. Carbon fiber reinforced PEEK Optima--a composite material biomechanical properties and wear/debris characteristics of CF-PEEK composites for orthopedic trauma implants. J Mech Behav Biomed Mater. 2013 Jan;17:221-8. doi: 10.1016/j.jmbbm.2012.09.013. Epub 2012 Oct 11.

  PMID: 23127632 BACKGROUND

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Andrea Pilloni, MD DDS Ms

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Pilloni, MD DDS MS

CONTACT

335/6409374; andrea.pilloni@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD DDS MS

Model Details: Patients of more than 18 years old without systemic disease/ disorders, smokers of less 5 cigarettes per day, periodontally healthy or treated with full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 15% at baseline with edentulous space needing an all on four or all on six treatment with overdenture width of the keratinized gingiva ≥ 2 at the level of the crest

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: March 9, 2018
• Study Start: September 6, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)