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Peri-implant MucositisNCT03693196

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

A study testing PICF, Perio-paper®, Subgingival Plaque, Hu-Friedy® and Williams probe, PCPNU-15 Hu-Friedy® in people with Peri-implant Mucositis and Peri-Implantitis, run by Necmettin Erbakan University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Peri-implant Mucositis, Peri-Implantitis
What is being tested?
PICF, Perio-paper®, Subgingival Plaque, Hu-Friedy® and Williams probe, PCPNU-15 Hu-Friedy®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
No sites listed yet
Study dates
Nov 2016to Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

About this study

Official title: The Effect of Different Dental Implant Surface Characteristics on Bone Immunological Biomarkers and Microbiological Parameters: A Randomized Clinical Study

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.

Read more

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.

Read the detailed description
  1. | INTRODUCTION Dental implants are commonly used in partly and completely edentulous patients in order to improve function, aesthetic appearance and life quality. Successful osseointegration is provided with recently developed surface modifications. Some of these are SLA (Sand-blasted, Largegrit, Acid-etched), fluorine modified surface and anodized surfaces. SLA implants are obtained by spraying large sand grits on the implant. Modification of dental implants with fluorine is a chemical method in which fluorine, one of the basic elements of bone, is added on the surface to increase osteogenesis. Implants with anodized surface form with micro or nano porous surfaces as a result of high intensity (200 A/m2) or potential (100 V) potansiostatic or galvanostatic anodization of titanium inside strong acids such as H2SO4, H3PO4, HNO3, HF. When this application is compared with passivated surfaces, it results in the thickening of titanium oxide layer. The objective of this study is to assess comparatively the levels of TNF-α, PGE2, RANKL, RANK, OPG, which are immunological markers of peri-implant disease and Porphyromonas gingivalis (P. gingivalis), Treponema denticola (T. denticola), Tannerella forsythia (T. forsythia), Fusobacterium nucleatum (F. nucleatum), Prevotella intermedia (P. intermedia), Streptococcus oralis (S. oralis), which are microbiological agents of peri implantitis, in areas where SLA, fluorine-modified and anodized implant surfaces are used.
  2. | MATERIAL AND METHODS 2.1 | Study Population The study was conducted by calling back patients whose partial missing teeth were treated with implant supported fixed restorations at Necmettin Erbakan University Faculty of Dentistry, Department of Periodontology and whose implants had been functioning for at least a year. The inclusion criteria of the study were 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, and having received one of SLA, fluorine modified or anodized implants. The exclusion criteria were uncontrolled diabetes mellitus and other uncontrolled diseases, pregnancy, lactation, aggressive periodontitis, overdenture patients and parafunctional habits such as bruxism. In the study, 71 implants of 37 patients, 24 females and 13 males, were assessed. The patients called were grouped in three according to the surface characteristics of the implants.

Group 1: Titanium implants the surfaces of which were roughened with SLA (sandblasted and acid-etched titanium surface) (Straumann®, Basel, Sweden), Group 2: Implants the surfaces of which were roughened by modifying with fluorine (Astra Tech, OsseoSpeed™, Sweden) Group 3: Implants the surfaces of which were roughened by anodization (TiUnite Nobel Biocare, Replace® Conical Connection, Sweden).

The implants included were grouped in three as healthy, peri-implant mucositis and peri-implantitis. Peri-implantitis group included implants which had bleeding and/or supuration at probing, pocket depth > 4 mm at least in one area and 2 mm or more radiographic bone loss around the implant, peri-implant mucositis group included implants which had bleeding and/or supuration at probing and no radiographic bone loss around the implant and the healthy group included implants which did not have inflammation around the implant, bleeding or supuration at probing and radiograph bone loss around the implant.

2.2 | Clinical Periodontal Measurements The indexes and measurements used in the study were measured within a specific order and recorded in data recording forms prepared according to this order. Plaque index (PI), gingival index (GI), pocket depths (PD), bleeding on probing, clinical attachment levels (CAL) and keratinized tissue width around the implant (KTW) were recorded. Panoramic radiographs were taken to assess the interproximal bone levels around the implant (Morita, Veraviewepocs 3D F40, Japan).

2.3 | Collecting the Peri-implant crevicular fluid (PICF) and Subgingival Plaque Samples After taking PI from all individuals, plaques and soft additions around the implant were removed and after the area was isolated with the help of cotton rolls, the teeth were dried with air. PICF was collected from the mesio-buccal area of the implant by using paper tapes (Perio-paper, Oraflow Inc, New York, USA). Subgingival plaque samples were collected about 15 minutes after PICF was collected.

2.4 | PICF analysis Commercial enzyme-linked immunosorbent assay (ELISA) kits were purchased for the measurement of TNF-α, PGE2, RANKL, RANK, OPG and assays were carried out according to the manufacturers' recommendations (Elabscience Biotechnology Co.,Ltd, Wuhan, China).

2.5 | Preparation and Assessment of Genomic DNA Forthe 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 instructions of the manufacturer.

2.6 | Real-Time Quantitative Polymerase Chain Reaction Selected putative periodontal pathogens (P. intermedia, T. forsythia, T.denticola, F. nucleatum, P.gingivalis, Streptococcus oralis) and total bacterial load in the subgingival biofilms were detected as described previously.

2.7 | Statistical Analysis SPSS 19.0 (IBM Inc., Chicago, IL, USA) program was used for the statistical analyses of the study. Normality test for continuous numerical variables was conducted with Kolmogorov-Smirnov analysis method. Since all of the variables were not normally distributed, non-parametrical methods were preferred in the analyses. Mann-Whitney U method was preferred for two independent groups, while Kruskal-Wallis was used for multiple groups. p<0,05 was accepted statistically significant.

Being tested
PICF, Perio-paper®, Subgingival Plaque, Hu-Friedy®, Williams probe, PCPNU-15 Hu-Friedy®, Demographic
Keywords
Dental implant, Immunology, Microbiology, Surface characteristic
Medical subject headings
Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

  • 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.

  • DemographicOther

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

Study groups in NCT03693196
Study groupRoleWhat they receive
Straumann®OtherTitanium 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.
Receives: Other: PICF, Perio-paper®; Other: Subgingival Plaque, Hu-Friedy®; Other: Williams probe, PCPNU-15 Hu-Friedy®; Other: Demographic
Astra Tech, OsseoSpeed™OtherImplants 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.
Receives: Other: PICF, Perio-paper®; Other: Subgingival Plaque, Hu-Friedy®; Other: Williams probe, PCPNU-15 Hu-Friedy®; Other: Demographic
Nobel Biocare, Replace®OtherImplants 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.
Receives: Other: PICF, Perio-paper®; Other: Subgingival Plaque, Hu-Friedy®; Other: Williams probe, PCPNU-15 Hu-Friedy®; Other: Demographic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: an average of 1 year

Secondary outcomes (1)
  1. Commercial enzyme-linked immunosorbent assay (ELISA) kits

    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).

    Measured: an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2018
  2. Study startNov 2016
  3. Primary completionFeb 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03693196
Sponsor's protocol ID
2016/009
Status last verified
Oct 2018
First submitted
7 May 2018
Last updated
2 Oct 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28440740
  • 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.

    PubMed 16904738
  • 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.

    PubMed 21323716
  • 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.

    PubMed 25503901
  • 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.

    PubMed 26701919
  • 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.

    PubMed 18828812

Questions about this trial

What is this clinical trial studying?

A study testing PICF, Perio-paper®, Subgingival Plaque, Hu-Friedy® and Williams probe, PCPNU-15 Hu-Friedy® in people with Peri-implant Mucositis and Peri-Implantitis, run by Necmettin Erbakan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Real-time polymerase chain reaction (PCR) (time frame: an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03693196, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.

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