NCT05535049

Brief Summary

Two different studies were planned from the recruited samples. The aim of these studies was to investigate the effect of non-surgical periodontal treatment on the inflammatory markers levels in serum and gingival crevicular fluid (GCF) in patients with periodontitis. There were two groups consisting of individuals who had periodontitis and those who were healthy, with 24 individuals in each group. Periostin levels were assessed at baseline, at the 24th h, 48th h, 14th day 1st month, 3rd month after non-surgical periodontal treatment in serum and GCF samples by the Elisa method in the first study. In parallel, interleukin 1 (IL)-beta and fibroblast growth factor levels were measured. Progranulin levels were assessed at baseline, at the 24th h, 48th h, 14th day 1st month, 3rd month after non-surgical periodontal treatment in serum and GCF samples by the Luminex method in the second study. In parallel, vascular endothelial growth factor, IL-1 beta, tumor necrosis factor-alpha, and IL-10 levels were measured.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

1.7 years

First QC Date

September 6, 2022

Last Update Submit

October 8, 2023

Conditions

Periodontal Treatment, Cytokines

Keywords

PeriodontitisPeriostinPeriodontal treatmentGingival crevicular fluid

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Periostin levels in non-surgical periodontal treatment

    The effect of non-surgical periodontal treatment on serum and gingival crevicular fluid periostin levels

    0-3 month

Secondary Outcomes (1)

  • Evaluation of IL-1B and FGF levels in non-surgical periodontal treatment

    0-3 month

Study Arms (2)

Periodontally healthy group

NO INTERVENTION

24 participants were included in this group.

Periodontitis group

ACTIVE COMPARATOR

24 participants were included in this group.

Procedure: Non-surgical periodontal treatment

Interventions

Non-surgical periodontal treatmentPROCEDURE

Full month non-surgical periodontal treatment procedure was applied to the periodontitis group.

Periodontitis group

Eligibility Criteria

Age24 Years - 58 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • individuals who had never smoked;
  • individuals who had no history of periodontal treatment in the past 6 months;
  • individuals who had had no antibiotic therapy in the past 3 months;
  • individuals who had more than 18 teeth.

You may not qualify if:

  • individuals who were pregnant;
  • individuals were current or former smokers;
  • individuals who had any self-reported systemic condition or disease, which are confounding factors e.g. AIDS, rheumatoid arthritis, cardiovascular diseases, diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustafa Kemal University

Hatay, 31000, Turkey (Türkiye)

Location

Related Publications (17)

  • Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.

    PMID: 1058834RESULT

  • Caton JG, Armitage G, Berglundh T, Chapple ILC, Jepsen S, Kornman KS, Mealey BL, Papapanou PN, Sanz M, Tonetti MS. A new classification scheme for periodontal and peri-implant diseases and conditions - Introduction and key changes from the 1999 classification. J Periodontol. 2018 Jun;89 Suppl 1:S1-S8. doi: 10.1002/JPER.18-0157.

    PMID: 29926946RESULT

  • Chapple IL, Landini G, Griffiths GS, Patel NC, Ward RS. Calibration of the Periotron 8000 and 6000 by polynomial regression. J Periodontal Res. 1999 Feb;34(2):79-86. doi: 10.1111/j.1600-0765.1999.tb02226.x.

    PMID: 10207836RESULT

  • Chapple IL, Mason GI, Garner I, Matthews JB, Thorpe GH, Maxwell SR, Whitehead TP. Enhanced chemiluminescent assay for measuring the total antioxidant capacity of serum, saliva and crevicular fluid. Ann Clin Biochem. 1997 Jul;34 ( Pt 4):412-21. doi: 10.1177/000456329703400413.

    PMID: 9247675RESULT

  • LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

    PMID: 14121956RESULT

  • Quirynen M, Bollen CM, Vandekerckhove BN, Dekeyser C, Papaioannou W, Eyssen H. Full- vs. partial-mouth disinfection in the treatment of periodontal infections: short-term clinical and microbiological observations. J Dent Res. 1995 Aug;74(8):1459-67. doi: 10.1177/00220345950740080501.

    PMID: 7560400RESULT

  • Rudin HJ, Overdiek HF, Rateitschak KH. Correlation between sulcus fluid rate and clinical and histological inflammation of the marginal gingiva. Helv Odontol Acta. 1970 Apr;14(1):21-6. No abstract available.

    PMID: 5438796RESULT

  • Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010 Jun 1;152(11):726-32. doi: 10.7326/0003-4819-152-11-201006010-00232. Epub 2010 Mar 24.

    PMID: 20335313RESULT

  • SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

    PMID: 14158464RESULT

  • Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945.

    PMID: 29926495RESULT

  • Tonetti MS, Sanz M. Implementation of the new classification of periodontal diseases: Decision-making algorithms for clinical practice and education. J Clin Periodontol. 2019 Apr;46(4):398-405. doi: 10.1111/jcpe.13104.

    PMID: 30883878RESULT

  • Yang N, Li Y, Wang G, Ding Y, Jin Y, Xu Y. Tumor necrosis factor-alpha suppresses adipogenic and osteogenic differentiation of human periodontal ligament stem cell by inhibiting miR-21/Spry1 functional axis. Differentiation. 2017 Sep-Oct;97:33-43. doi: 10.1016/j.diff.2017.08.004. Epub 2017 Sep 1.

    PMID: 28946056RESULT

  • Daniel R, He Z, Carmichael KP, Halper J, Bateman A. Cellular localization of gene expression for progranulin. J Histochem Cytochem. 2000 Jul;48(7):999-1009. doi: 10.1177/002215540004800713.

    PMID: 10858277RESULT

  • Li X, Zuo Z, Chen Q, Li J, Tang W, Yang P. Progranulin is highly expressed in patients with chronic periodontitis and protects against experimental periodontitis in rats. J Periodontol. 2018 Dec;89(12):1418-1427. doi: 10.1002/JPER.18-0132. Epub 2018 Sep 11.

    PMID: 29999528RESULT

  • Horiuchi K, Amizuka N, Takeshita S, Takamatsu H, Katsuura M, Ozawa H, Toyama Y, Bonewald LF, Kudo A. Identification and characterization of a novel protein, periostin, with restricted expression to periosteum and periodontal ligament and increased expression by transforming growth factor beta. J Bone Miner Res. 1999 Jul;14(7):1239-49. doi: 10.1359/jbmr.1999.14.7.1239.

    PMID: 10404027RESULT

  • Matsuzawa M, Arai C, Nomura Y, Murata T, Yamakoshi Y, Oida S, Hanada N, Nakamura Y. Periostin of human periodontal ligament fibroblasts promotes migration of human mesenchymal stem cell through the alphavbeta3 integrin/FAK/PI3K/Akt pathway. J Periodontal Res. 2015 Dec;50(6):855-63. doi: 10.1111/jre.12277. Epub 2015 Apr 20.

    PMID: 25900259RESULT

  • Sari A, Santamaria P, Nibali L. The effect of non-surgical periodontal treatment on progranulin levels. J Periodontol. 2025 Aug 25. doi: 10.1002/jper.11396. Online ahead of print.

    PMID: 40853679DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Aysegul Sari, PhD

    Hatay Mustafa Kemal University Dental Faculty

    PRINCIPAL INVESTIGATOR

  • Oguzhan Ozcan, Prof

    Hatay Mustafa Kemal University Medical Faculty

    STUDY CHAIR

  • Alpdogan Kantarci, Prof

    Boston University Goldman School of Dental Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific research projects

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 10, 2022

Study Start

December 1, 2019

Primary Completion

August 1, 2021

Study Completion

November 1, 2021

Last Updated

October 11, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)