PeriodontitisNCT04663165
Biomarkers for Periodontitis Relapse
A study testing Periodontal surgery and Regenerative periodontal surgery in people with Periodontitis, run by Anders Holmlund at 2 sites in Sweden.
Trial summary
In this clinical study, we have collected GCF at diseased teeth and at the same time drawn blood, both before and at 3, 6 and 12 months after periodontal surgical treatment. This give us the opportunity to investigate if periodontal treatment could reduce inflammatory biomarkers in the systemic circulation and if… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periodontitis
- What is being tested?
- Periodontal surgery and Regenerative periodontal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesSweden
- Study dates
- 4 Feb 2010to 12 Jan 2015
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient with diagnosed periodontitis
- at least three teeth with ≥ 4mm loss of bone support detected at radiograph, combined with periodontal pocket depth ≥5mm and bleeding on probing and/or pus, in two quadrants
Who cannot join
- periodontal therapy the last 3 months
- intake of antibiotic the last 3 months
- intake of anti-inflammatory drug the last 2 weeks before collection of samples
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Specialist Clinic in Dental Care, Gävle Hospital, Public Dental Health Gävleborg AB, Region Gävleborg
Gävle, Gävleborg County, 801 87
Specialist Clinic in Dental Care, Gävle Hospital, Public Dental Health Gävleborg, Region Gävleborg
Gävle, Gävleborg County, 801 87
About this study
Official title: Biomarkers in Gingival Exudate and Blood Serum Before and After Surgical Treatment of Periodontitis
In this clinical study, we have collected GCF at diseased teeth and at the same time drawn blood, both before and at 3, 6 and 12 months after periodontal surgical treatment. This give us the opportunity to investigate if periodontal treatment could reduce inflammatory biomarkers in the systemic circulation and if there is a co-variation between biomarkers in GCF and blood.
In part I of this study, we focus on biomarkers from blood serum in patients with periodontitis, before surgical therapy and under a healing period 12 months.
Read more
In part II, biomarkers in the locally collected GCF will be analyzed together with clinically reported measurements and compared with biomarkers in blood serum.
Hypothesis are
- Periodontal treatment followed by clinical healing and periodontal health will be associated a change/ reduction in biomarkers in GCF.
- The systemic levels of inflammatory biomarkers may show a delayed response to clinical healing. Periodontal surgical therapy may reduce circulating inflammatory biomarkers that could affect the low-grade chronic inflammation.
- There is a co-variation between inflammatory biomarkers in GCF and the systemic circulation.
Read the detailed description
Periodontitis, a disease affecting the tissue supporting the tooth, is initiated by microbes colonizing the tooth causing an inflammation of the soft tissue around the tooth. In some sensitive individuals the inflammatory response leads to loss of jawbone, which affect the bone support of the tooth and may end up in loss of teeth. Periodontitis is the sixth most prevalent disease in the world, 40% of the population with affected jawbone support and approximately 10% of the population suffer from severe loss of the supporting jawbone at teeth. Periodontitis may be halted or resolved by removing the microbial biofilm from the teeth root and in severe cases combined with surgical treatment removing inflammatory tissue. The genetic factors explain approximately 50% of the disease, and but the etiology is in parts unclear and effective therapy in sensitive individuals is still missing.
The inflammatory response initiated by microbes leads to degradation of the tooth supporting tissues. The current view is that pro-inflammatory cytokines and prostaglandins, produced by leukocytes and cells of mesenchymal origin in the inflamed tissue are responsible for recruiting and activation of bone-resorbing cells, osteoclasts. The inflammatory biomarkers and tissue degradation products will leak out into the exudate in the gingival pocket next to the root surface. The bone resorption activity connected to changes in biomarkers levels and clinical parameters, during healing after periodontal treatment seem to be of value to study. The analysis of the local exudate (gingival crevicular fluid, GCF) could be used for predicting and monitoring periodontitis, as well as finding new targets for treatment.
Periodontitis could also have a systemic effect, as locally released inflammatory mediators might enter the systemic circulation and influence the development of inflammatory conditions such as cardiovascular disease (CVD), diabetes and rheumatoid arthritis. Earlier studies have shown that a low-grade chronic inflammation plays an important role in the pathogenies in atherosclerosis. Substances that indicate low-grade chronic inflammation in blood serum is for example levels of C-reactive protein (CRP), fibrinogen, and adhesion-molecules, and these biomarkers are related to CVD. The question is if periodontal treatment could change/reduce the systemic inflammatory burden of inflammatory biomarkers (CRP, fibrinogen, interleukins, and matrix metalloproteinases (MMP)).
We know today that there is association between oral health and CVD, but we do not know if the relationship it is of a causal nature. There are some intervention studies that indicate that the oral inflammatory burden may have a systemic effect. To better understand the role of the oral inflammation in development of atherosclerosis, it is important to study biomarkers at different timepoints both from the local sites (GCF) and the general systemic environment in blood. If there is a co-variation in levels of inflammatory biomarkers locally in the GCF and in the systemic circulation, this could be a strong indication of a more causal nature of the association, but we need more studies.
The value of the study is to better understand what drives the local disease progression in periodontitis and also increase the knowledge by which mechanism the oral inflammation could exert its systemic effect. Measuring levels of biomarkers in GCF and serum at several timepoints after treatment we may contribute with new insights in the role of inflammatory inducing molecules in periodontal disease, but also if there exists any systemic effect from locally released inflammatory mediators. The possibility that some molecules co-variate with disease progression or regression is of great value.
The possible co-variation of molecules with disease progression or regression is important knowledge in understanding how oral infection may affect the general health.
Part I: Serum biomarkers for periodontitis relapse Part II: GCF biomarkers for periodontal healing and relapse
This is a prospective clinical intervention study to investigate healing of severe periodontitis sites after periodontal surgical therapy and in what extent the clinical healing is associated with changes of the inflammatory expression of biomarkers in gingival crevicular fluid (GCF) and in blood serum.
21 patients were recruited consecutively and treated surgically of one experienced specialist in periodontology. Two teeth in different quadrants per patient, with the deepest pocket measured, were selected and included in the study. Periodontal surgery was performed and at 13 of the teeth an additional treatment with enamel matrix derivative (EMD/Emdogain®) were performed. Registration of full mouth plaque score (FMPS), periodontal pocket depth (PPD), bleeding on probing (BOP) or pus were performed before surgery, after 3, 6 and 12 months. Radiographs were taken at examination before treatment and at the follow-up at 12 months.
Blood samples and samples of gingival crevicular fluid (GCF) were collected before and at the follow-up visits 3, 6 and 12 months after surgical treatment. GCF samples was labelled and stored at -80°C.
Blood samples were drawn and handled by the chemical laboratory at Gävle hospital in conjunction to therapy and follow-up points. Blood were collected from each patient and 5x1mL serum was labelled and stored at -80°C.
Protein analysis on blood sera and GCF performed and concentrations of 92 proteins were assessed by proximity extension assay (Olink Bioscience, Sweden) using the Inflammation panel.
Vascular Injury Panel 2 Human Kit (Meso Scale Diagnostics) were used to assess concentration of C-Reactive Protein (CRP), Intercellular Adhesion Molecule-1 (ICAM-1), Serum Amyloid A (SAA) and Vascular Cell Adhesion Molecule-1 (VCAM-1) in sera.
- Conditions
- Periodontitis
- Being tested
- Periodontal surgery, Regenerative periodontal surgery
- Keywords
- Periodontitis, Gingival crevicular fluid (GCF), Serum, Inflammation
- Medical subject headings
- Periodontitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal surgeryProcedure or surgery
Flap surgery at teeth with periodontal pocket depth 5 mm or more with additional bleeding or pus on probing. Elimination of dental calculus and granulation tissue as well as scaling of the root surface with scalers and ultrasonic device. Flap closure with non-resorbable sutures.
Regenerative periodontal surgeryProcedure or surgery
Flap surgery at teeth with periodontal pocket depth 5 mm or more with additional bleeding or pus on probing combined with vertical bone defect of 4mm or more. After elimination of dental calculus and granulation tissue as well as scaling of the root surface with scalers and ultrasonic device, adjunctive treatment with EDTA gel applied to root surface for two minutes, followed by rinsing with saline solution. Finally, application of enamel matrix derivative on a blood free root surface, followed by flap closure with non-resorbable sutures.
| Study group | Role | What they receive |
|---|---|---|
| Flap surgery alone | Other | Access flap Receives: Procedure: Periodontal surgery |
| Flap surgery with adjunctive EMD | Other | Access flap and adjunctive enamel matrix derivative Receives: Procedure: Regenerative periodontal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing (BOP) 3 months
Change in BOP
Measured: between baseline and 3 months after treatment
Bleeding on probing (BOP) 6 months
Change in BOP
Measured: between baseline and 6 months after treatment
Bleeding on probing (BOP) 12 months
Change in BOP
Measured: between baseline and 12 months after treatment
Periodontal pocket depth (PPD) 3 months
Change in PPD
Measured: between baseline and 3 months after treatment
Periodontal pocket depth (PPD) 6 months
Change in PPD
Measured: between baseline and 6 months after treatment
Periodontal pocket depth (PPD) 12 months
Change in PPD
Measured: between baseline and 12 months after treatment
Plaque Index (PLI) 3 months
Change in PLI
Measured: between baseline and 3 months after treatment
Plaque Index (PLI) 6 months
Change in PLI
Measured: between baseline and 6 months after treatment
Plaque Index (PLI) 12 months
Change in PLI
Measured: between baseline and 12 months after treatment
Biomarkers in blood serum 3 months
Change in serum protein profile using Inflammation panel (92 proteins) by Olink Bioscience plus V-PLEX Vascular Injury Panel 2 Human Kit to assess concentration of CRP, ICAM-1, SAA and VCAM-1.
Measured: between baseline and 3 months after treatment
Biomarkers in blood serum 6 months
Change in serum protein profile using Inflammation panel (92 proteins) by Olink Bioscience plus V-PLEX Vascular Injury Panel 2 Human Kit to assess concentration of CRP, ICAM-1, SAA and VCAM-1.
Measured: between baseline and 6 months after treatment
Biomarkers in blood serum 12 months
Change in serum protein profile using Inflammation panel (92 proteins) by Olink Bioscience plus V-PLEX Vascular Injury Panel 2 Human Kit to assess concentration of CRP, ICAM-1, SAA and VCAM-1.
Measured: between baseline and 12 months after treatment
Biomarkers in gingival crevicular fluid (GCF) 3 months
Change in GCF protein profile using Inflammation panel (92 proteins) by Olink Bioscience.
Measured: between baseline and 3 months after treatment
Biomarkers in gingival crevicular fluid (GCF) 6 months
Change in GCF protein profile using Inflammation panel (92 proteins) by Olink Bioscience.
Measured: between baseline and 6 months after treatment
Biomarkers in gingival crevicular fluid (GCF) 12 months
Change in GCF protein profile using Inflammation panel (92 proteins) by Olink Bioscience.
Measured: between baseline and 12 months after treatment
Secondary outcomes (12)
Association between BOP and serum protein profile 3 months
Change in serum protein profile in relation to the clinical parameter bleeding on probing (BOP)
Measured: between baseline and 3 months after treatment
Association between BOP and serum protein profile 6 months
Change in serum protein profile in relation to the clinical parameter bleeding on probing (BOP)
Measured: between baseline and 6 months after treatment
Association between BOP and serum protein profile 12 months
Change in serum protein profile in relation to the clinical parameter bleeding on probing (BOP)
Measured: between baseline and 12 months after treatment
Association between PPD and serum protein profile 3 months
Change in serum protein profile in relation to the clinical parameter periodontal pocket depth (PPD)
Measured: between baseline and 3 months after treatment
Association between PPD and serum protein profile 6 months
Change in serum protein profile in relation to the clinical parameter periodontal pocket depth (PPD)
Measured: between baseline and 6 months after treatment
Association between PPD and serum protein profile 12 months
Change in serum protein profile in relation to the clinical parameter periodontal pocket depth (PPD)
Measured: between baseline and 12 months after treatment
Association between BOP and GCF protein profile 3 months
Change in protein profile in the gingival crevicular fluid (GCF) in relation to the clinical parameters bleeding on probing (BOP)
Measured: between baseline and 3 months after treatment
Association between BOP and GCF protein profile 6 months
Change in protein profile in the gingival crevicular fluid (GCF) in relation to the clinical parameters bleeding on probing (BOP)
Measured: between baseline and 6 months after treatment
Association between BOP and GCF protein profile 12 months
Change in protein profile in the gingival crevicular fluid (GCF) in relation to the clinical parameters bleeding on probing (BOP)
Measured: between baseline and 12 months after treatment
Association between PPD and GCF protein profile 3 months
Change in protein profile in the gingival crevicular fluid (GCF) in relation to the clinical parameters probing pocket depth (PPD)
Measured: between baseline and 3 months after treatment
Association between PPD and GCF protein profile 6 months
Change in protein profile in the gingival crevicular fluid (GCF) in relation to the clinical parameters probing pocket depth (PPD)
Measured: between baseline and 6 months after treatment
Association between PPD and GCF protein profile 12 months
Change in protein profile in the gingival crevicular fluid (GCF) in relation to the clinical parameters probing pocket depth (PPD)
Measured: between baseline and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start4 Feb 2010
- Primary completion23 Sep 2013
- Study completion12 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- a clinical prospective interventional study with longterm follow-up
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anders Holmlund
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University
- Responsible party
- Sponsor-investigator, Anders Holmlund, Region Gävleborg
- Investigators
- Lundberg, Prof., Principal investigator, Department of Molecular Periodontology, Umeå University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663165
- Sponsor's protocol ID
- 476871q
- Status last verified
- Dec 2020
- First submitted
- 12 Nov 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frencken JE, Sharma P, Stenhouse L, Green D, Laverty D, Dietrich T. Global epidemiology of dental caries and severe periodontitis - a comprehensive review. J Clin Periodontol. 2017 Mar;44 Suppl 18:S94-S105. doi: 10.1111/jcpe.12677.
PubMed 28266116Page RC. The role of inflammatory mediators in the pathogenesis of periodontal disease. J Periodontal Res. 1991 May;26(3 Pt 2):230-42. doi: 10.1111/j.1600-0765.1991.tb01649.x.
PubMed 1679130Lerner UH, Modeer T, Krekmanova L, Claesson R, Rasmussen L. Gingival crevicular fluid from patients with periodontitis contains bone resorbing activity. Eur J Oral Sci. 1998 Jun;106(3):778-87. doi: 10.1046/j.0909-8836.1998.eos106304.x.
PubMed 9672100Holmlund A, Hanstrom L, Lerner UH. Bone resorbing activity and cytokine levels in gingival crevicular fluid before and after treatment of periodontal disease. J Clin Periodontol. 2004 Jun;31(6):475-82. doi: 10.1111/j.1600-051X.2004.00504.x.
PubMed 15142219Stadler AF, Angst PD, Arce RM, Gomes SC, Oppermann RV, Susin C. Gingival crevicular fluid levels of cytokines/chemokines in chronic periodontitis: a meta-analysis. J Clin Periodontol. 2016 Sep;43(9):727-45. doi: 10.1111/jcpe.12557. Epub 2016 Jun 23.
PubMed 27027257Danesh J, Whincup P, Walker M, Lennon L, Thomson A, Appleby P, Gallimore JR, Pepys MB. Low grade inflammation and coronary heart disease: prospective study and updated meta-analyses. BMJ. 2000 Jul 22;321(7255):199-204. doi: 10.1136/bmj.321.7255.199.
PubMed 10903648D'Aiuto F, Parkar M, Andreou G, Suvan J, Brett PM, Ready D, Tonetti MS. Periodontitis and systemic inflammation: control of the local infection is associated with a reduction in serum inflammatory markers. J Dent Res. 2004 Feb;83(2):156-60. doi: 10.1177/154405910408300214.
PubMed 14742655Kolny M, Stasiowski MJ, Zuber M, Marciniak R, Chabierska E, Pluta A, Jalowiecki P, Byrczek T. Randomized, comparative study of the effectiveness of three different techniques of interscalene brachial plexus block using 0.5% ropivacaine for shoulder arthroscopy. Anaesthesiol Intensive Ther. 2017;49(1):47-52. doi: 10.5603/AIT.2017.0009.
PubMed 28362032Holmlund A, Lampa E, Lind L. Poor Response to Periodontal Treatment May Predict Future Cardiovascular Disease. J Dent Res. 2017 Jul;96(7):768-773. doi: 10.1177/0022034517701901. Epub 2017 Mar 31.
PubMed 28363032
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Gingival Exudate and Blood Serum Before and After Surgical Treatment of Periodontitis
- ClinicalTrials.gov ID
- NCT04663165
- Acronym / sponsor ID
- 476871q
- Conditions
- Periodontitis
- Keywords
- Periodontitis, Gingival crevicular fluid (GCF), Serum, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Anders HolmlundUniversity, hospital or other
- Collaborators
- Umeå University
- Study start
- 4 Feb 2010 (actual)
- Primary completion
- 23 Sep 2013 (actual)
- Study completion
- 12 Jan 2015 (actual)
- First posted
- 10 Dec 2020 (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.
In this clinical study, we have collected GCF at diseased teeth and at the same time drawn blood, both before and at 3, 6 and 12 months after periodontal surgical treatment. This give us the opportunity to investigate if periodontal treatment could reduce inflammatory biomarkers in the systemic circulation and if there is a co-variation between biomarkers in GCF and blood.
In part I of this study, we focus on biomarkers from blood serum in patients with periodontitis, before surgical therapy and under a healing period 12 months.
In part II, biomarkers in the locally collected GCF will be analyzed together with clinically reported measurements and compared with biomarkers in blood serum.
Hypothesis are
- Periodontal treatment followed by clinical healing and periodontal health will be associated a change/ reduction in biomarkers in GCF.
- The systemic levels of inflammatory biomarkers may show a delayed response to clinical healing. Periodontal surgical therapy may reduce circulating inflammatory biomarkers that could affect the low-grade chronic inflammation.
- There is a co-variation between inflammatory biomarkers in GCF and the systemic circulation.
Detailed description
Periodontitis, a disease affecting the tissue supporting the tooth, is initiated by microbes colonizing the tooth causing an inflammation of the soft tissue around the tooth. In some sensitive individuals the inflammatory response leads to loss of jawbone, which affect the bone support of the tooth and may end up in loss of teeth. Periodontitis is the sixth most prevalent disease in the world, 40% of the population with affected jawbone support and approximately 10% of the population suffer from severe loss of the supporting jawbone at teeth. Periodontitis may be halted or resolved by removing the microbial biofilm from the teeth root and in severe cases combined with surgical treatment removing inflammatory tissue. The genetic factors explain approximately 50% of the disease, and but the etiology is in parts unclear and effective therapy in sensitive individuals is still missing.
The inflammatory response initiated by microbes leads to degradation of the tooth supporting tissues. The current view is that pro-inflammatory cytokines and prostaglandins, produced by leukocytes and cells of mesenchymal origin in the inflamed tissue are responsible for recruiting and activation of bone-resorbing cells, osteoclasts. The inflammatory biomarkers and tissue degradation products will leak out into the exudate in the gingival pocket next to the root surface. The bone resorption activity connected to changes in biomarkers levels and clinical parameters, during healing after periodontal treatment seem to be of value to study. The analysis of the local exudate (gingival crevicular fluid, GCF) could be used for predicting and monitoring periodontitis, as well as finding new targets for treatment.
Periodontitis could also have a systemic effect, as locally released inflammatory mediators might enter the systemic circulation and influence the development of inflammatory conditions such as cardiovascular disease (CVD), diabetes and rheumatoid arthritis. Earlier studies have shown that a low-grade chronic inflammation plays an important role in the pathogenies in atherosclerosis. Substances that indicate low-grade chronic inflammation in blood serum is for example levels of C-reactive protein (CRP), fibrinogen, and adhesion-molecules, and these biomarkers are related to CVD. The question is if periodontal treatment could change/reduce the systemic inflammatory burden of inflammatory biomarkers (CRP, fibrinogen, interleukins, and matrix metalloproteinases (MMP)).
We know today that there is association between oral health and CVD, but we do not know if the relationship it is of a causal nature. There are some intervention studies that indicate that the oral inflammatory burden may have a systemic effect. To better understand the role of the oral inflammation in development of atherosclerosis, it is important to study biomarkers at different timepoints both from the local sites (GCF) and the general systemic environment in blood. If there is a co-variation in levels of inflammatory biomarkers locally in the GCF and in the systemic circulation, this could be a strong indication of a more causal nature of the association, but we need more studies.
The value of the study is to better understand what drives the local disease progression in periodontitis and also increase the knowledge by which mechanism the oral inflammation could exert its systemic effect. Measuring levels of biomarkers in GCF and serum at several timepoints after treatment we may contribute with new insights in the role of inflammatory inducing molecules in periodontal disease, but also if there exists any systemic effect from locally released inflammatory mediators. The possibility that some molecules co-variate with disease progression or regression is of great value.
The possible co-variation of molecules with disease progression or regression is important knowledge in understanding how oral infection may affect the general health.
Part I: Serum biomarkers for periodontitis relapse Part II: GCF biomarkers for periodontal healing and relapse
This is a prospective clinical intervention study to investigate healing of severe periodontitis sites after periodontal surgical therapy and in what extent the clinical healing is associated with changes of the inflammatory expression of biomarkers in gingival crevicular fluid (GCF) and in blood serum.
21 patients were recruited consecutively and treated surgically of one experienced specialist in periodontology. Two teeth in different quadrants per patient, with the deepest pocket measured, were selected and included in the study. Periodontal surgery was performed and at 13 of the teeth an additional treatment with enamel matrix derivative (EMD/Emdogain®) were performed. Registration of full mouth plaque score (FMPS), periodontal pocket depth (PPD), bleeding on probing (BOP) or pus were performed before surgery, after 3, 6 and 12 months. Radiographs were taken at examination before treatment and at the follow-up at 12 months.
Blood samples and samples of gingival crevicular fluid (GCF) were collected before and at the follow-up visits 3, 6 and 12 months after surgical treatment. GCF samples was labelled and stored at -80°C.
Blood samples were drawn and handled by the chemical laboratory at Gävle hospital in conjunction to therapy and follow-up points. Blood were collected from each patient and 5x1mL serum was labelled and stored at -80°C.
Protein analysis on blood sera and GCF performed and concentrations of 92 proteins were assessed by proximity extension assay (Olink Bioscience, Sweden) using the Inflammation panel.
Vascular Injury Panel 2 Human Kit (Meso Scale Diagnostics) were used to assess concentration of C-Reactive Protein (CRP), Intercellular Adhesion Molecule-1 (ICAM-1), Serum Amyloid A (SAA) and Vascular Cell Adhesion Molecule-1 (VCAM-1) in sera.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a clinical prospective interventional study with longterm follow-up
| Arm | Type | Receives |
|---|---|---|
| Flap surgery alone | Other | Procedure: Periodontal surgeryAccess flap |
| Flap surgery with adjunctive EMD | Other | Procedure: Regenerative periodontal surgeryAccess flap and adjunctive enamel matrix derivative |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patient with diagnosed periodontitis
- at least three teeth with ≥ 4mm loss of bone support detected at radiograph, combined with periodontal pocket depth ≥5mm and bleeding on probing and/or pus, in two quadrants
Key exclusion criteria (3 listed)
- periodontal therapy the last 3 months
- intake of antibiotic the last 3 months
- intake of anti-inflammatory drug the last 2 weeks before collection of samples
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 |
|---|---|---|
| Periodontal surgeryFlap surgery at teeth with periodontal pocket depth 5 mm or more with additional bleeding or pus on probing. Elimination of dental calculus and granulation tissue as well as scaling of the root surface with scalers and ultrasonic device. Flap closure with non-resorbable sutures. | Procedure or surgery | Flap surgery alone |
| Regenerative periodontal surgeryFlap surgery at teeth with periodontal pocket depth 5 mm or more with additional bleeding or pus on probing combined with vertical bone defect of 4mm or more. After elimination of dental calculus and granulation tissue as well as scaling of the root surface with scalers and ultrasonic device, adjunctive treatment with EDTA gel applied to root surface for two minutes, followed by rinsing with saline solution. Finally, application of enamel matrix derivative on a blood free root surface, followed by flap closure with non-resorbable sutures. | Procedure or surgery | Flap surgery with adjunctive EMD |
Primary outcome
Bleeding on probing (BOP) 3 months
Time frame: between baseline and 3 months after treatment
Change in BOP
Bleeding on probing (BOP) 6 months
Time frame: between baseline and 6 months after treatment
Change in BOP
Bleeding on probing (BOP) 12 months
Time frame: between baseline and 12 months after treatment
Change in BOP
Periodontal pocket depth (PPD) 3 months
Time frame: between baseline and 3 months after treatment
Change in PPD
Periodontal pocket depth (PPD) 6 months
Time frame: between baseline and 6 months after treatment
Change in PPD
Periodontal pocket depth (PPD) 12 months
Time frame: between baseline and 12 months after treatment
Change in PPD
Plaque Index (PLI) 3 months
Time frame: between baseline and 3 months after treatment
Change in PLI
Plaque Index (PLI) 6 months
Time frame: between baseline and 6 months after treatment
Change in PLI
Plaque Index (PLI) 12 months
Time frame: between baseline and 12 months after treatment
Change in PLI
Biomarkers in blood serum 3 months
Time frame: between baseline and 3 months after treatment
Change in serum protein profile using Inflammation panel (92 proteins) by Olink Bioscience plus V-PLEX Vascular Injury Panel 2 Human Kit to assess concentration of CRP, ICAM-1, SAA and VCAM-1.
Biomarkers in blood serum 6 months
Time frame: between baseline and 6 months after treatment
Change in serum protein profile using Inflammation panel (92 proteins) by Olink Bioscience plus V-PLEX Vascular Injury Panel 2 Human Kit to assess concentration of CRP, ICAM-1, SAA and VCAM-1.
Biomarkers in blood serum 12 months
Time frame: between baseline and 12 months after treatment
Change in serum protein profile using Inflammation panel (92 proteins) by Olink Bioscience plus V-PLEX Vascular Injury Panel 2 Human Kit to assess concentration of CRP, ICAM-1, SAA and VCAM-1.
Biomarkers in gingival crevicular fluid (GCF) 3 months
Time frame: between baseline and 3 months after treatment
Change in GCF protein profile using Inflammation panel (92 proteins) by Olink Bioscience.
Biomarkers in gingival crevicular fluid (GCF) 6 months
Time frame: between baseline and 6 months after treatment
Change in GCF protein profile using Inflammation panel (92 proteins) by Olink Bioscience.
Biomarkers in gingival crevicular fluid (GCF) 12 months
Time frame: between baseline and 12 months after treatment
Change in GCF protein profile using Inflammation panel (92 proteins) by Olink Bioscience.
12 secondary outcomes
Association between BOP and serum protein profile 3 months
Time frame: between baseline and 3 months after treatment
Association between BOP and serum protein profile 6 months
Time frame: between baseline and 6 months after treatment
Association between BOP and serum protein profile 12 months
Time frame: between baseline and 12 months after treatment
Association between PPD and serum protein profile 3 months
Time frame: between baseline and 3 months after treatment
Association between PPD and serum protein profile 6 months
Time frame: between baseline and 6 months after treatment
Association between PPD and serum protein profile 12 months
Time frame: between baseline and 12 months after treatment
Association between BOP and GCF protein profile 3 months
Time frame: between baseline and 3 months after treatment
Association between BOP and GCF protein profile 6 months
Time frame: between baseline and 6 months after treatment
Association between BOP and GCF protein profile 12 months
Time frame: between baseline and 12 months after treatment
Association between PPD and GCF protein profile 3 months
Time frame: between baseline and 3 months after treatment
Association between PPD and GCF protein profile 6 months
Time frame: between baseline and 6 months after treatment
Association between PPD and GCF protein profile 12 months
Time frame: between baseline and 12 months after treatment
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 10 Dec 2020.
- Background: PubMed 28266116Frencken JE, Sharma P, Stenhouse L, Green D, Laverty D, Dietrich T. Global epidemiology of dental caries and severe periodontitis - a comprehensive review. J Clin Periodontol. 2017 Mar;44 Suppl 18:S94-S105. doi: 10.1111/jcpe.12677.
- Background: PubMed 1679130Page RC. The role of inflammatory mediators in the pathogenesis of periodontal disease. J Periodontal Res. 1991 May;26(3 Pt 2):230-42. doi: 10.1111/j.1600-0765.1991.tb01649.x.
- Background: PubMed 9672100Lerner UH, Modeer T, Krekmanova L, Claesson R, Rasmussen L. Gingival crevicular fluid from patients with periodontitis contains bone resorbing activity. Eur J Oral Sci. 1998 Jun;106(3):778-87. doi: 10.1046/j.0909-8836.1998.eos106304.x.
- Background: PubMed 15142219Holmlund A, Hanstrom L, Lerner UH. Bone resorbing activity and cytokine levels in gingival crevicular fluid before and after treatment of periodontal disease. J Clin Periodontol. 2004 Jun;31(6):475-82. doi: 10.1111/j.1600-051X.2004.00504.x.
- Background: PubMed 27027257Stadler AF, Angst PD, Arce RM, Gomes SC, Oppermann RV, Susin C. Gingival crevicular fluid levels of cytokines/chemokines in chronic periodontitis: a meta-analysis. J Clin Periodontol. 2016 Sep;43(9):727-45. doi: 10.1111/jcpe.12557. Epub 2016 Jun 23.
- Background: PubMed 10903648Danesh J, Whincup P, Walker M, Lennon L, Thomson A, Appleby P, Gallimore JR, Pepys MB. Low grade inflammation and coronary heart disease: prospective study and updated meta-analyses. BMJ. 2000 Jul 22;321(7255):199-204. doi: 10.1136/bmj.321.7255.199.
- Background: PubMed 14742655D'Aiuto F, Parkar M, Andreou G, Suvan J, Brett PM, Ready D, Tonetti MS. Periodontitis and systemic inflammation: control of the local infection is associated with a reduction in serum inflammatory markers. J Dent Res. 2004 Feb;83(2):156-60. doi: 10.1177/154405910408300214.
- Background: PubMed 28362032Kolny M, Stasiowski MJ, Zuber M, Marciniak R, Chabierska E, Pluta A, Jalowiecki P, Byrczek T. Randomized, comparative study of the effectiveness of three different techniques of interscalene brachial plexus block using 0.5% ropivacaine for shoulder arthroscopy. Anaesthesiol Intensive Ther. 2017;49(1):47-52. doi: 10.5603/AIT.2017.0009.
- Background: PubMed 28363032Holmlund A, Lampa E, Lind L. Poor Response to Periodontal Treatment May Predict Future Cardiovascular Disease. J Dent Res. 2017 Jul;96(7):768-773. doi: 10.1177/0022034517701901. Epub 2017 Mar 31.
- Individual participant dataSharing planned: No
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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.
Lundberg, Prof. principal investigator
Department of Molecular Periodontology, Umeå University, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal surgery and Regenerative periodontal surgery in people with Periodontitis, run by Anders Holmlund at 2 sites in Sweden.
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 2 inclusion and 3 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 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Bleeding on probing (BOP) 3 months (time frame: between baseline and 3 months after treatment). The study lists 15 primary outcomes in all. 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 NCT04663165, which also lists 9 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 10 Dec 2020.