Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03693196
Recruitment Status : Completed
First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
BİLGE KARCI, Necmettin Erbakan University

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.


Condition or disease Intervention/treatment Phase
Peri-implant Mucositis Peri-Implantitis Other: PICF, Perio-paper® Other: Subgingival Plaque, Hu-Friedy® Other: Williams probe, PCPNU-15 Hu-Friedy® Other: Demographic Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Different Dental Implant Surface Characteristics on Bone Immunological Biomarkers and Microbiological Parameters: A Randomized Clinical Study
Actual Study Start Date : November 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : November 2017

Arm Intervention/treatment
Straumann®
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®
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.

Other: Subgingival Plaque, Hu-Friedy®
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.

Other: Williams probe, PCPNU-15 Hu-Friedy®
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.

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

Astra Tech, OsseoSpeed™
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®
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.

Other: Subgingival Plaque, Hu-Friedy®
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.

Other: Williams probe, PCPNU-15 Hu-Friedy®
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.

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

Nobel Biocare, Replace®
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®
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.

Other: Subgingival Plaque, Hu-Friedy®
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.

Other: Williams probe, PCPNU-15 Hu-Friedy®
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.

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




Primary Outcome Measures :
  1. Real-time polymerase chain reaction (PCR) [ Time Frame: an average of 1 year ]
    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.


Secondary Outcome Measures :
  1. Commercial enzyme-linked immunosorbent assay (ELISA) kits [ Time Frame: an average of 1 year ]
    ELISA kits were purchased for measuring TNF-α, PGE2, RANKL, RANK, and OPG, and assays were carried out according to the manufacturers' recommendations (Elabscience Biotechnology Co., Ltd, Wuhan, China).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693196


Sponsors and Collaborators
Necmettin Erbakan University
Investigators
Layout table for investigator information
Study Director: Elif Öncü Necmettin Erbakan University, Faculty of Dentistry, Department of Periodontology, Konya, Turkey
Study Chair: Metin Doğan Necmettin Erbakan University, Meram Faculty of Medicine, Department of Microbiology, Konya, Turkey

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: BİLGE KARCI, Research assistant, Necmettin Erbakan University
ClinicalTrials.gov Identifier: NCT03693196     History of Changes
Other Study ID Numbers: 2016/009
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BİLGE KARCI, Necmettin Erbakan University:
Dental implant
Immunology
Microbiology
Surface characteristic
Additional relevant MeSH terms:
Layout table for MeSH terms
Mucositis
Peri-Implantitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Diseases