NCT07254117 The Role of Granulation Tissue in Periodontal Regeneration
| NCT ID | NCT07254117 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Riga Stradins University |
| Condition | Periodontal Bone Loss |
| Study Type | OBSERVATIONAL |
| Enrollment | 46 participants |
| Start Date | 2025-05-29 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 46 participants in total. It began in 2025-05-29 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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?
Eligibility Criteria
Inclusion Criteria: 1. Both genders. 2. Systemically healthy. 3. 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). 4. Patients aged 18 years and over. 5. 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. 6. Patients with a plaque index and bleeding on probing of 20% or lower before surgery. Exclusion Criteria: 1. 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). 2. 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)). 3. Current pregnancy and/or breastfeeding. 4. Patients who have received any form of systemic antibiotics in the last six months prior to the start of the study. 5. Patients who require antibiotic premedication prior to periodontal treatment. 6. Prosthetic factors in teeth associated with suitable bone defects that prevent clinical measurements. 7. Lack of patient motivation to undertake adequate dental care at home or to complete periodontal treatment. 8. Strong vomiting reflex preventing adequate periodontal treatment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07254117 clinical trial?
This trial is open to participants of all sexes, studying Periodontal Bone Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07254117 currently recruiting?
Yes, NCT07254117 is actively recruiting participants. Contact the research team at dartaemulina@gmail.com for enrollment information.
Where is the NCT07254117 trial being conducted?
This trial is being conducted at Riga, Latvia.
Who is sponsoring the NCT07254117 clinical trial?
NCT07254117 is sponsored by Riga Stradins University. The trial plans to enroll 46 participants.