Periodontitis
Conditions
Keywords
GBT, Periodontitis, SI
Brief summary
The aim of this clinical trial is to evaluate and compare the effect of a newly designed air-polishing device (APD) using Erythritol, Glycine, and Trehalose air-polishing powders in nonsurgical periodontal therapy with control (conventional scaling and root planning) following the concept of guided biofilm therapy (GBT) as an adjunctive to subgingival instrumentation (SI) in nonsurgical periodontal therapy for Stage II and III periodontitis patients both clinically and microbiologically.
Interventions
DEVICEGBT and SI with erythritol powder
Non-Surgical Periodontal treatment: 1. Guided Biofilm Therapy * Guided supragingival and shallow subgingival (PD ≥ 4 mm) removal of biofilm and stains from all quadrants using the air-polishing device using a standard nozzle system. * Subgingival removal of biofilm from deeper periodontal pockets (PD ≥ 6 mm) using an Air-polishing device subgingival nozzle system with erythritol powder . 2. Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only.
OTHERGBT and SI with glycine powder
Non-Surgical Periodontal treatment: 1. Guided Biofilm Therapy • Guided supragingival and shallow subgingival (PD ≥ 4 mm) removal of biofilm and stains from all quadrants using the air-polishing device using a standard nozzle system. • Subgingival removal of biofilm from deeper periodontal pockets (PD ≥ 6 mm) using an Air-polishing device subgingival nozzle system with glycine powder. 2. Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only
OTHERGBT and SI with trehalose powder
Non-Surgical Periodontal treatment: 1. Guided Biofilm Therapy • Guided supragingival and shallow subgingival (PD ≥ 4 mm) removal of biofilm and stains from all quadrants using the air-polishing device using a standard nozzle system. • Subgingival removal of biofilm from deeper periodontal pockets (PD ≥ 6 mm) using an Air-polishing device subgingival nozzle system with trehalose powder . 2. Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only
OTHERSRP and SI
conventional scaling and root planning (SRP) with subgingival instrumentation only will be performed
Sponsors
Diana Ibrahim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Individuals of both sexes with an age between 30 and 65 years, having at least 16 natural teeth in function, 2. Stage II and III (moderate to severe) periodontitis, having at least 16 teeth with the need for SI 3. Interproximal plaque index (API) ≤ 35%; patients with Good oral hygiene. 4. No history of systemic disease that may influence periodontal disease
Exclusion criteria
1. Pregnancy or breastfeeding, 2. Smokers with more than seven cigarettes per day 3. Patients that had a treatment with antibiotics within six months before the study 4. Need for periodontal surgery or adjunctive antibiotic treatment to the SI 5. Patients who had any periodontal treatment during the last year before the study. 6. Patients with known systemic or autoimmune disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on probing | up to six months | — |
| Pain Assessment | up to six months | Pain level will be assed using Visual Analogue Scale (VAS) from 1 (minimum) to 10 (maximum) |
| Probing depth | up to six months | — |
| Plaque accumulation | up to six months | — |
| Clinical attachment level | up to six months | — |
| Microbiological Assessment of Aggregatibacter actinomycetemcomitans (Aa) | one month | — |
| Microbiological Assessment of Porphyromonas gingivalis (Pg) | one month | — |
| Microbiological Assessment of Tannerella forsythia (Tf) | one month | — |
| Microbiological Assessment of Treponema denticola (Td) | one month | — |
Countries
Egypt
Outcome results
None listed