How different gum granulation tissues affect bone healing in severe periodontitis
The Role of Biochemical and Microbiological Properties of Granulation Tissue in Periodontal Regeneration
This observational study will test whether infra‑osseous and supra‑osseous granulation tissues help healing after periodontal surgery in adults with severe periodontitis and whether smoking changes those properties.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 46 (estimated) |
| Sex | All |
| Sponsor | Riga Stradins University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Riga) |
| Trial ID | NCT07254117 on ClinicalTrials.gov |
What this trial studies
This observational study collects gingival crevicular fluid and granulation tissue samples at the time of periodontal surgery from adults with severe periodontitis. Researchers will use proteomics to profile pro‑healing and regenerative proteins in infra‑osseous versus supra‑osseous granulation tissues and will perform microbiome analyses to characterize infectious components. Smoking and non‑smoking participants will be compared to determine whether tobacco use alters regenerative markers or microbial virulence. Clinical periodontal measures and radiographs will be recorded to relate tissue findings to defect severity and healing potential.
Who should consider this trial
Good fit: Adults aged 18 or older who are systemically healthy with stage III or IV periodontitis and at least one residual vertical bone defect (≥3 mm infrabony component) in the premolar/molar region, who meet the smoking/non‑smoking definitions and have plaque index and bleeding on probing ≤20% before surgery.
Not a fit: Patients with systemic illnesses or conditions that affect healing (for example uncontrolled diabetes, recent myocardial infarction or stroke, bleeding disorders), recent antibiotic use, or those on medications that affect bone/metabolism, and patients without qualifying vertical defects or who cannot undergo surgical sampling are unlikely to benefit.
Why it matters
Potential benefit: If successful, the findings could identify which granulation tissue types best support regeneration and inform surgical or biological strategies to improve periodontal healing.
How similar studies have performed: Comparable proteomic and microbiome analyses of periodontal tissues have provided preliminary insights, but using granulation tissue specifically to guide regeneration is relatively novel and not yet proven clinically.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Riga
- Riga Stradins University Institute of Stomatology — Riga, Latvia (Recruiting)
Study contacts
- Study coordinator: Dārta E Emuliņa, DDS
- Email: dartaemulina@gmail.com
- Phone: +37122007988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.