Periodontitis, Periodontitis (Stage 3)
Conditions
Brief summary
The study was designed to evaluate the concept of the clean & seal, using sodium hypochlorite gel and hyaluronic acid as adjunctive to non-surgical therapy for management of Stage III Periodontitis.
Interventions
OTHERScaling and root planing with sodium hypochlorite and hyaluronic acid
Sodium hypochlorite gel was applied first for 30 seconds, then followed by subgingival instrumentation of the site. Then, 1.8% hyaluronic acid (1.6% cross-linked, 0.2% natural hyaluronic acid ) was applied subgingivally into the periodontal pocket to seal the site.
PROCEDUREScaling and root planing
Pockets were treated with sub-gingival scalling and root planning alone.
Sponsors
Karim Ismail
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients of both sexes diagnosed with periodontitis Stage III. * CAL ≥ 5mm or bone loss affecting middle third of the root in more than two adjacent teeth. * PPD ≥ 6mm in more than two adjacent teeth. * Periodontal tooth loss ≤ 4 teeth. * Systemically healthy patients.
Exclusion criteria
* Patient with uncontrolled diabetes. * Pregnant or lactating. * Tobacco smoker ≥ 10 cigarettes/day. * Antibiotic treatment within previous 4 weeks. * Acute periodontal or periapical abscess
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque accumulation | up to 12 weeks | This was assessed using O'Leary plaque index. The O'Leary Plaque Index records the presence or absence of dental plaque on four surfaces (mesial, distal, buccal, lingual) of each tooth. The score ranges from 0% (no plaque) to 100% (plaque on all surfaces), with lower percentages indicating better oral hygiene. |
| Gingival condition assessment | up to 12 weeks | The Gingival Index of Löe and Silness was used to assess the severity of gingival inflammation based on color, consistency, and bleeding on probing across four areas per tooth. Scores range from 0 (normal gingiva) to 3 (severe inflammation with spontaneous bleeding), with higher scores indicating worse gingival health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth | up to 12 weeks | Probing Depth is the measurement of the distance from the gingival margin to the bottom of the periodontal pocket using a periodontal probe. Values typically range from 1-3 mm (healthy) to ≥5 mm (indicative of periodontal disease), with deeper pockets reflecting more severe attachment loss. |
| Clinical attachment loss | up to 12 weeks | Clinical Attachment Loss measures the distance from the cementoenamel junction to the base of the periodontal pocket, indicating the extent of periodontal support lost. Values range from 0 mm (no attachment loss) to ≥5 mm or more (severe loss), with higher measurements reflecting greater periodontal destruction. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Microbiological assessment of P. gingivalis | 6 weeks | The bacteriological parameter by using Real Time PCR was used to evaluate the Porphyromonas gingivalis load. Sub-gingival plaque samples were taken by removing of the supra-gingival plaque with curette and cotton pellets before inserting , sterile endodontic paper points in periodontal pocket and leaving them in situ for 10 seconds. The paper points were immediately transferred to sterile , dry cryovials . Paper points were stored frozen at -80 ºC immediately after sample collection until being processed with PCR. |
Countries
Egypt
Outcome results
None listed