The Role of Granulation Tissue in Periodontal Regeneration

NCT07254117 | Recruiting

• 1 other identifier: 2-PĒK-4/434/2025
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to distinguish the infectious, healing, and regeneration-related characteristics of two types of gingival granulation tissues, namely infra-osseous and supra-osseous granulation tissues, in people with severe periodontitis (gum disease). Researchers aim to denote if these tissues may play role in healing after periodontal treatment. Researchers will also compare smokers and non-smokers to see if smoking disrupts the healing potential or infectious properties of granulation tissue. Participants will provide gingival fluid (before) and granulation tissue samples (at the time of) periodontal surgery. The main questions this study aims to answer are: 1. Do infra- and supra-osseous granulation tissues have different healing potential and infectious properties? 2. How do these tissues differ in people who smoke compared to people who do not smoke?

Conditions

Periodontal Bone Loss; Periodontitis; Periodontal Disease; Periodontal Diseases; Periodontal Regeneration; Periodontal Granulation Tissue; Vertical Periodontal Bone Defects; Periodontal Healing

Keywords

Periodontal granulation tissue; Periodontitis; Vertical periodontal bone defects; Vertical defects; Granulation tissue; Periodontal regeneration; Periodontal healing

Outcome Measures

Primary Outcomes (1)

• Comparison of pro-healing/regenerative markers and microbial composition/virulence profiles in infra-osseous and supra-osseous granulation tissues between smokers and non-smokers with Stage III-IV Grade B-C periodontitis.

  Regenerative markers: IL-1β, IL-6, TNF-α (pro-inflammatory), IL-4, IL-10 (anti-inflammatory), CCL-2/MCP-1, CCL-8/MCP-2, CXCL9/MIG, CCL-3/MIP-1α (macrophage-activation related chemokines), osteoprotegerin, RANKL, osteocalcin, osteopontin (bone-remodeling markers). Microbial outcomes: presence, abundance, and virulence characteristics of bacteria in infra- and supra-osseous granulation tissue.

  May 2025 - September 2028

Secondary Outcomes (2)

• Differences in regenerative and microbial markers between infra-osseous and supra-osseous granulation tissues within the non-smoking group.

  May 2025 - September 2028

• Effect of smoking on selected regenerative and virulence markers in infra-osseous granulation tissue.

  May 2025 - September 2028

Other Outcomes (1)

• Correlation between tissue biochemical/microbial markers and clinical periodontal parameters.

  May 2025 - September 2028

Study Arms (2)

Non-smoking periodontitis patients

Non-smoking Stage III-IV Grade B-C periodontitis patients with at least one infra-osseous approximal bone defect (with ≥3 mm infrabony component) at premolar-molar region (n=23).

Smoking periodontitis patients

Smoking Stage III-IV Grade B-C periodontitis patients with at least one infra-osseous approximal bone defect (with ≥3 mm infrabony component) at premolar-molar region (n=23).

Eligibility Criteria

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

Study Population

The study will be formed of two study groups: 1. Non-smoking Stage III-IV Grade B-C periodontitis patients with at least one infra-osseous approximal bone defect (with ≥3 mm infrabony component) at premolar-molar region (n=23). 2. Smoking Stage III-IV Grade B-C periodontitis patients with at least one infra-osseous approximal bone defect (with ≥3 mm infrabony component) at premolar-molar region (n=23). The sample size for the present cross-sectional study was determined using R (package pwr, function pwr.t.test with type=paired). The effect size, Cohen's D = 0.941, was derived from the Interleukin-10 (IL-10) to total protein ratio. The total sample size was calculated to be 46 patients in two equally sized dependent groups, with a power of 99% (beta = 0.01) and an alpha of 0.05. All patients will be recruited from among those enrolled in Riga Stradins University Institute of Stomatology Periodontology Department maintenance treatment program.

You may qualify if:

• Both genders.
• Systemically healthy.
• Both smokers (smoking at least 10 cigarettes a day or electronic cigarettes daily or quit less than 5 years ago) and non-smokers (never smoked, smoke no more than once a month or quit at least 5 years ago).
• Patients aged 18 years and over.
• Patients with a history of severe periodontitis (stage III or IV, grade B-C) and, after completion of the non-surgical stage of periodontal treatment with at least one residual vertical bone defects (with ≥3 mm infrabony component) in premolar-molar region.
• Patients with a plaque index and bleeding on probing of 20% or lower before surgery.

You may not qualify if:

• Systemic diseases that may affect study results (uncontrolled type 2 diabetes mellitus (HBA1c level of \>7%); recent (less than 6 months ago) myocardial infarction or stroke; blood coagulation disorders; recent use of antibiotics (less than 6 months).
• Use of medications that may affect study results (anti-osteoporotic drugs, statins, corticosteroids, calcium channel blockers, cyclosporine A, antiepileptic drugs, antipsychotic medication or antidepressants, chemotherapy and/or radiotherapy (active or history)).
• Current pregnancy and/or breastfeeding.
• Patients who have received any form of systemic antibiotics in the last six months prior to the start of the study.
• Patients who require antibiotic premedication prior to periodontal treatment.
• Prosthetic factors in teeth associated with suitable bone defects that prevent clinical measurements.
• Lack of patient motivation to undertake adequate dental care at home or to complete periodontal treatment.
• Strong vomiting reflex preventing adequate periodontal treatment.

Sponsors & Collaborators

• Riga Stradins University: lead
• University of Turku: collaborator

Study Sites (1)

Riga Stradins University Institute of Stomatology

Riga, LV-1013, Latvia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Periodontal granulation tissue samples

MeSH Terms

Conditions

Alveolar Bone Loss; Periodontitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Dārta E Emuliņa, DDS

CONTACT

+37122007988; dartaemulina@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: May 29, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)