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.
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
- | 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.
- | 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.
- Conditions
- Peri-implant Mucositis, Peri-Implantitis
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. 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.
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)
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.
- First posted2 Oct 2018
- Study startNov 2016
- Primary completionFeb 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peri-implant MucositisStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BİLGE KARCI, Necmettin Erbakan University
- Investigators
- Elif Öncü, Study director, Necmettin Erbakan University, Faculty of Dentistry, Department of Periodontology, Konya, TurkeyMetin Doğan, Study chair, Necmettin Erbakan University, Meram Faculty of Medicine, Department of Microbiology, Konya, Turkey
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 28440740Le 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 16904738Mombelli 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 21323716Derks 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 25503901Derks 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 26701919Shibli 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Dental Implant Surface Characteristics on Bone Immunological Biomarkers and Microbiological Parameters: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03693196
- Acronym / sponsor ID
- 2016/009
- Conditions
- Peri-implant Mucositis, Peri-Implantitis
- Keywords
- Dental implant, Immunology, Microbiology, Surface characteristic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- | 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.
- | 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Straumann® | Other | Other: PICF, Perio-paper®, Other: Subgingival Plaque, Hu-Friedy®, Other: Williams probe, PCPNU-15 Hu-Friedy®, Other: DemographicTitanium 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. |
| Astra Tech, OsseoSpeed™ | Other | Other: PICF, Perio-paper®, Other: Subgingival Plaque, Hu-Friedy®, Other: Williams probe, PCPNU-15 Hu-Friedy®, Other: DemographicImplants 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. |
| Nobel Biocare, Replace® | Other | Other: PICF, Perio-paper®, Other: Subgingival Plaque, Hu-Friedy®, Other: Williams probe, PCPNU-15 Hu-Friedy®, Other: DemographicImplants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (6 listed)
- uncontrolled diabetes mellitus and other uncontrolled diseases,
- pregnancy,
- lactation,
- aggressive periodontitis,
- overdenture patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Astra Tech, OsseoSpeed™, Nobel Biocare, Replace®, Straumann® |
| 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 | Astra Tech, OsseoSpeed™, Nobel Biocare, Replace®, Straumann® |
| 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 | Astra Tech, OsseoSpeed™, Nobel Biocare, Replace®, Straumann® |
| DemographicAge, gender and state of smoking were compared between groups. | Other | Astra Tech, OsseoSpeed™, Nobel Biocare, Replace®, Straumann® |
Primary outcome
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.
1 secondary outcome
Commercial enzyme-linked immunosorbent assay (ELISA) kits
Time frame: an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Background: PubMed 28440740Gurlek 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.
- Background: PubMed 16904738Le 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.
- Background: PubMed 21323716Mombelli 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.
- Results publication: PubMed 25503901Derks 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.
- Results publication: PubMed 26701919Derks 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.
- Results publication: PubMed 18828812Shibli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Öncü study director
Necmettin Erbakan University, Faculty of Dentistry, Department of Periodontology, Konya, Turkey
Metin Doğan study chair
Necmettin Erbakan University, Meram Faculty of Medicine, Department of Microbiology, Konya, Turkey
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.