The Effect of Different Dental Implant Surface Characteristics on Immunological and Microbiological Parameters

NCT03693196 | Completed

• 1 other identifier: 2016/009
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives: To assess the levels of TNF-α, PGE2, RANKL, RANK, OPG, which are immunological markers of peri-implant disease and F. nucleatum, P. gingivalis, T. denticola, T. forsythia, P. intermedia, S. oralis, which are microbiological agents of peri-implantitis, in areas where SLA, fluorine-modified and anodized implant surfaces are used. Material and methods: In this study, 71 implants of 37 patients were assessed. The patients were grouped according to the surface characteristics of the implants. Group 1: SLA surface, Group 2: Fluorine modifying surface, Group 3:Anodization surface Plaque index (PI), gingival index (GI), bleeding on probing (BOP), pocket depths (PD), clinical attachment levels (CAL) and keratinized tissue width (KTW) were measured. Peri-implant sulcus fluid and subgingival plaque samples were collected. Results: PI was found to be significantly lowest in Group 1, higher in Group 3. Group 3 implants were found to have more bleeding on probing significantly. It was found to be higher peri-implant mucositis and peri-implantitis in Group 3. GI, PD, CAL, KTW were not found to differ between groups. No significant differences were found between TNF-α, PGE2, RANKL, RANK, OPG. While F. nucleatum, T. forsythia, T. denticola and P. intermedia were found to be significant highest in Group 3, P. gingivalis and S. oralis were found to be high in Group 2. Conclusion: Peri-implantitis rate, BOP and PI were found to be higher in Group 3. F. nucleatum, T. forsythia, T. denticola, and P. intermedia were found to be significantly high in Group 3 implants. This situation can be associated with the porous structure of anodized surface.

Conditions

Peri-implant Mucositis; Peri-Implantitis

Keywords

Dental implant; Immunology; Microbiology; Surface characteristic

Outcome Measures

Primary Outcomes (1)

• Real-time polymerase chain reaction (PCR)

  For DNA extraction, the collected subgingival plaque samples were processed using a commercially available kit (GF-1 bacterial DNA extraction kit, Vivantis, Malaysia) according to the manufacturer's instructions. Selected putative periodontal pathogens and total bacterial load in the subgingival biofilms were detected as described previously.

  an average of 1 year

Secondary Outcomes (1)

• Commercial enzyme-linked immunosorbent assay (ELISA) kits

  an average of 1 year

Study Arms (3)

Straumann®

OTHER

Titanium implants the surfaces of which were roughened with SLA (sandblasted and acid-etched titanium surface) (Straumann®, Basel, Sweden). Immunological parameters (PICF, Perio-paper®) , microbiological parameters of peri-implantitis (subgingival plaque, Hu-Friedy®), demographic and clinical periodontal measurements (Williams probe, PCPNU-15 Hu-Friedy®) were compared between groups.

Other: PICF, Perio-paper®; Other: Subgingival Plaque, Hu-Friedy®; Other: Williams probe, PCPNU-15 Hu-Friedy®; Other: Demographic

Astra Tech, OsseoSpeed™

OTHER

Implants the surfaces of which were roughened by modifying with fluorine (Astra Tech, OsseoSpeed™, Sweden). Immunological parameters (PICF, Perio-paper®), microbiological parameters of peri-implantitis (subgingival plaque, Hu-Friedy®), demographic and clinical periodontal measurements (Williams probe, PCPNU-15 Hu-Friedy®) were compared between groups.

Other: PICF, Perio-paper®; Other: Subgingival Plaque, Hu-Friedy®; Other: Williams probe, PCPNU-15 Hu-Friedy®; Other: Demographic

Nobel Biocare, Replace®

OTHER

Implants the surfaces of which were roughened by anodization (TiUnite Nobel Biocare, Replace® Conical Connection, Sweden). Immunological parameters (PICF, Perio-paper®), microbiological parameters of peri-implantitis(subgingival plaque, Hu-Friedy®), demographic and clinical periodontal measurements (Williams probe, PCPNU-15 Hu-Friedy®) were compared between groups.

Other: PICF, Perio-paper®; Other: Subgingival Plaque, Hu-Friedy®; Other: Williams probe, PCPNU-15 Hu-Friedy®; Other: Demographic

Interventions

PICF, Perio-paper® OTHER

PICF was collected from the mesio-buccal area of the implant by using paper tapes. Paper tapes were placed 1-2 mm inside the peri-implant sulcus by using a dental tweezer. After they were kept for 30 s, the paper tapes were placed in sterile microcentrifuge tubes which contained 200 µL phosphate-buffered saline (PBS). The tubes were kept at -80°C until the analysis day. TNF-α, PGE2, RANKL, RANK, and OPG, which are immunological markers of peri-implant disease were compared between groups.

Astra Tech, OsseoSpeed™; Nobel Biocare, Replace®; Straumann®

Subgingival Plaque, Hu-Friedy® OTHER

Subgingival plaque samples were collected about 15 min after PICF was collected. Supragingival plaque was carefully removed by using a sterile scale. Implants were isolated using cotton rolls and dried with an air spray. Subgingival plaque samples were collected from the mesio-buccal area of the implant by using sterile plastic Gracey curettes during 30 s (Hu-Friedy). The samples collected were transferred to sterile microcentrifuge tubes containing 200 µL PBS. The tubes were kept at -80°C until the analysis day. Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Fusobacterium nucleatum, Prevotella intermedia, and Streptococcus oralis, which are microbiological agents of peri-implantitis were compared between groups.

Astra Tech, OsseoSpeed™; Nobel Biocare, Replace®; Straumann®

Williams probe, PCPNU-15 Hu-Friedy® OTHER

Clinical periodontal measurements were recorded using Williams probe. The plaque index, gingival index, pocket depth, bleeding on probing, clinical attachment level, and keratinised tissue width around the implant were recorded. The implants included were categorised into three groups, namely, healthy, peri-implant mucositis, and peri-implantitis. Panoramic radiographs were acquired to assess the interproximal bone levels around the implant.

Astra Tech, OsseoSpeed™; Nobel Biocare, Replace®; Straumann®

Demographic OTHER

Age, gender and state of smoking were compared between groups.

Astra Tech, OsseoSpeed™; Nobel Biocare, Replace®; Straumann®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• not having any systemic disorders that can affect bone metabolism and wound healing,
• being older than 18,
• having prostheses in the posterior area,
• having received cement retained implant prosthesis in which standard abutment was used,
• having implant prosthesis which had been functioning for at least a year,
• not having received bone augmentation procedure or advanced implant surgery during implant surgery,
• not having received periodontal treatment during the previous year,
• having received one of SLA, fluorine modified or anodized implants.

You may not qualify if:

• uncontrolled diabetes mellitus and other uncontrolled diseases,
• pregnancy,
• lactation,
• aggressive periodontitis,
• overdenture patients
• parafunctional habits such as bruxism.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Related Publications (6)

• Gurlek O, Gumus P, Nile CJ, Lappin DF, Buduneli N. Biomarkers and Bacteria Around Implants and Natural Teeth in the Same Individuals. J Periodontol. 2017 Aug;88(8):752-761. doi: 10.1902/jop.2017.160751. Epub 2017 Apr 25.

  PMID: 28440740 BACKGROUND

• Le Guehennec L, Soueidan A, Layrolle P, Amouriq Y. Surface treatments of titanium dental implants for rapid osseointegration. Dent Mater. 2007 Jul;23(7):844-54. doi: 10.1016/j.dental.2006.06.025. Epub 2006 Aug 14.

  PMID: 16904738 BACKGROUND

• Mombelli A, Decaillet F. The characteristics of biofilms in peri-implant disease. J Clin Periodontol. 2011 Mar;38 Suppl 11:203-13. doi: 10.1111/j.1600-051X.2010.01666.x.

  PMID: 21323716 BACKGROUND

• Derks J, Hakansson J, Wennstrom JL, Tomasi C, Larsson M, Berglundh T. Effectiveness of implant therapy analyzed in a Swedish population: early and late implant loss. J Dent Res. 2015 Mar;94(3 Suppl):44S-51S. doi: 10.1177/0022034514563077. Epub 2014 Dec 11.

  PMID: 25503901 RESULT

• Derks J, Schaller D, Hakansson J, Wennstrom JL, Tomasi C, Berglundh T. Effectiveness of Implant Therapy Analyzed in a Swedish Population: Prevalence of Peri-implantitis. J Dent Res. 2016 Jan;95(1):43-9. doi: 10.1177/0022034515608832.

  PMID: 26701919 RESULT

• Shibli JA, Melo L, Ferrari DS, Figueiredo LC, Faveri M, Feres M. Composition of supra- and subgingival biofilm of subjects with healthy and diseased implants. Clin Oral Implants Res. 2008 Oct;19(10):975-82. doi: 10.1111/j.1600-0501.2008.01566.x.

  PMID: 18828812 RESULT

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Demography

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Elif Öncü

  Necmettin Erbakan University, Faculty of Dentistry, Department of Periodontology, Konya, Turkey

  STUDY DIRECTOR

• Metin Doğan

  Necmettin Erbakan University, Meram Faculty of Medicine, Department of Microbiology, Konya, Turkey

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: October 2, 2018
• Study Start: November 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 2, 2018

Record last verified: 2018-10