Angiogenesis in Periodontal Disease

NCT07765251 | Completed

• 1 other identifier: 2023-3374
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Gum disease (gingivitis and periodontitis) is a common inflammatory condition affecting the tissues that support the teeth. Smoking is known to make gum disease worse and to affect blood vessel health in the gums. This study looks at two proteins, KLF2 and FBXW7, which are involved in blood vessel formation, to understand their role in gum disease and whether smoking changes their levels. Researchers measured these proteins, along with two other markers of inflammation and blood vessel activity (VEGF and NF-κB), in fluid collected from around the teeth and in saliva from healthy adults who were either smokers or non-smokers, with healthy gums, gingivitis, or periodontitis. The goal is to better understand how smoking and gum disease affect blood vessel-related proteins in the mouth.

Conditions

Gingivitis

Keywords

periodontitis; gingivitis; smoking; angiogenesis

Outcome Measures

Primary Outcomes (1)

• GCF and Salivary VEGF, NF-κB, KLF2, and FBXW7 Protein Levels

  Total amounts and concentrations of VEGF, NF-κB, KLF2, and FBXW7 were measured by ELISA in gingival crevicular fluid (GCF) and unstimulated whole saliva samples, and compared across participants with periodontal health, gingivitis, and periodontitis, in both smokers and non-smokers.

  March to September 2024

Study Arms (6)

Group H

periodontally healthy and non smokers

Group G

gingivitis and non-smokers

Group P

periodontitis and non-smokers

Group S-H

periodontally healthy and non smokers

Group S-G

gingivitis and smokers

Group S-P

periodontitis and non-smokers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 to 65 years attending the periodontology clinic were enrolled and classified into 6 groups based on clinical periodontal parameters and smoking status according to the 2017 World Workshop classification: periodontal health, gingivitis, and periodontitis (Stage III Grade B). Exclusion criteria included any systemic disease, regular medication use, pregnancy or lactation, periodontal treatment within the past 6 months, antibiotic use within the past 6 months, and presence of prosthetic restorations on the teeth to be sampled. A total of 114 participants (19 per group; 56 males, 58 females) were included.

You may qualify if:

• presence of ≥ 20 teeth in the mouth
• probing pocket depth (PPD) ≤ 3 mm
• the percentage of bleeding sites for the whole mouth \< 10%,
• on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth.
• presence of ≥ 20 teeth in the mouth
• PPD ≤ 3 mm,
• % of bleeding sites for the whole mouth ≥ 10%,
• on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth.
• presence of ≥ 15 teeth in the mouth
• more than 30% of teeth affected by periodontal disease
• affected teeth exhibiting probing depths of 6 mm or more
• clinical attachment loss (CAL) of ≥ 5 mm,
• vertical bone loss of 3 mm or more
• class 2 or 3 furcation involvement
• radiographic evidence of alveolar bone loss extending to the middle third and beyond (33%) in the relevant teeth

You may not qualify if:

• presence of any systemic disease
• regular use of any medication
• pregnancy or lactation
• periodontal treatment within the last 6 months
• antibiotic use within the last 6 months
• the presence of prosthetic restorations on the teeth to be sampled

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University, Faculty of Dentistry, Deparment of Periodontology

Malatya, 44100, Turkey (Türkiye)

Location

Related Publications (4)

• Afacan B, Ozturk VO, Pasali C, Bozkurt E, Kose T, Emingil G. Gingival crevicular fluid and salivary HIF-1alpha, VEGF, and TNF-alpha levels in periodontal health and disease. J Periodontol. 2019 Jul;90(7):788-797. doi: 10.1002/JPER.18-0412. Epub 2018 Dec 11.

  PMID: 30536725 BACKGROUND

• Leite FRM, Nascimento GG, Scheutz F, Lopez R. Effect of Smoking on Periodontitis: A Systematic Review and Meta-regression. Am J Prev Med. 2018 Jun;54(6):831-841. doi: 10.1016/j.amepre.2018.02.014. Epub 2018 Apr 12.

  PMID: 29656920 BACKGROUND

• Kawanami D, Mahabeleshwar GH, Lin Z, Atkins GB, Hamik A, Haldar SM, Maemura K, Lamanna JC, Jain MK. Kruppel-like factor 2 inhibits hypoxia-inducible factor 1alpha expression and function in the endothelium. J Biol Chem. 2009 Jul 31;284(31):20522-30. doi: 10.1074/jbc.M109.025346. Epub 2009 Jun 1.

  PMID: 19491109 BACKGROUND

• Arabi A, Ullah K, Branca RM, Johansson J, Bandarra D, Haneklaus M, Fu J, Aries I, Nilsson P, Den Boer ML, Pokrovskaja K, Grander D, Xiao G, Rocha S, Lehtio J, Sangfelt O. Proteomic screen reveals Fbw7 as a modulator of the NF-kappaB pathway. Nat Commun. 2012;3:976. doi: 10.1038/ncomms1975.

  PMID: 22864569 BACKGROUND

MeSH Terms

Conditions

Gingivitis; Periodontitis; Smoking

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Behavior

Study Officials

• Kubra Aral, Phd

  Inonu University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start: March 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months and ending 24 months following article publicatio
• Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal, subject to approval by the corresponding author, for the purpose of achieving the aims outlined in the approved proposal.

Locations

TU (1)