Biomarkers for Periodontitis Relapse

NCT04663165 | Completed

• 1 other identifier: 476871q
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Periodontitis

Keywords

Periodontitis; Gingival crevicular fluid (GCF); Serum; Inflammation

Outcome Measures

Primary Outcomes (15)

• Bleeding on probing (BOP) 3 months

  Change in BOP

  between baseline and 3 months after treatment

• Bleeding on probing (BOP) 6 months

  Change in BOP

  between baseline and 6 months after treatment

• Bleeding on probing (BOP) 12 months

  Change in BOP

  between baseline and 12 months after treatment

• Periodontal pocket depth (PPD) 3 months

  Change in PPD

  between baseline and 3 months after treatment

• Periodontal pocket depth (PPD) 6 months

  Change in PPD

  between baseline and 6 months after treatment

• Periodontal pocket depth (PPD) 12 months

  Change in PPD

  between baseline and 12 months after treatment

• Plaque Index (PLI) 3 months

  Change in PLI

  between baseline and 3 months after treatment

• Plaque Index (PLI) 6 months

  Change in PLI

  between baseline and 6 months after treatment

• Plaque Index (PLI) 12 months

  Change in PLI

  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.

  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.

  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.

  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.

  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.

  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.

  between baseline and 12 months after treatment

Secondary Outcomes (12)

• Association between BOP and serum protein profile 3 months

  between baseline and 3 months after treatment

• Association between BOP and serum protein profile 6 months

  between baseline and 6 months after treatment

• Association between BOP and serum protein profile 12 months

  between baseline and 12 months after treatment

• Association between PPD and serum protein profile 3 months

  between baseline and 3 months after treatment

• Association between PPD and serum protein profile 6 months

  between baseline and 6 months after treatment

Study Arms (2)

Flap surgery alone

OTHER

Access flap

Procedure: Periodontal surgery

Flap surgery with adjunctive EMD

OTHER

Access flap and adjunctive enamel matrix derivative

Procedure: Regenerative periodontal surgery

Interventions

Periodontal surgery PROCEDURE

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.

Flap surgery alone

Regenerative periodontal surgery PROCEDURE

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.

Flap surgery with adjunctive EMD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anders Holmlund: lead
• Umeå University: collaborator

Study Sites (2)

Specialist Clinic in Dental Care, Gävle Hospital, Public Dental Health Gävleborg AB, Region Gävleborg

Gävle, Gävleborg County, 801 87, Sweden

Location

Specialist Clinic in Dental Care, Gävle Hospital, Public Dental Health Gävleborg, Region Gävleborg

Gävle, Gävleborg County, 801 87, Sweden

Location

Related Publications (9)

• 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.

  PMID: 28266116 BACKGROUND

• Page 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.

  PMID: 1679130 BACKGROUND

• Lerner 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.

  PMID: 9672100 BACKGROUND

• Holmlund 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.

  PMID: 15142219 BACKGROUND

• Stadler 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.

  PMID: 27027257 BACKGROUND

• Danesh 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.

  PMID: 10903648 BACKGROUND

• D'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.

  PMID: 14742655 BACKGROUND

• Kolny 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.

  PMID: 28362032 BACKGROUND

• Holmlund 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.

  PMID: 28363032 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Inflammation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lundberg, Prof.

  Department of Molecular Periodontology, Umeå University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary Investigator, Associated Professor

Model Details: a clinical prospective interventional study with longterm follow-up

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: December 10, 2020
• Study Start: February 4, 2010
• Primary Completion: September 23, 2013
• Study Completion: January 12, 2015
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)