Periodontitis
Conditions
Keywords
periodontitis, scaling and root planing, sodium hypochlorite
Brief summary
The aim of the study is to investigate clinical and microbiological effects of subgingival application of chloramine (Perisolv) and hyaluronic acid (Hyadent BG) gels as adjuncts to scaling and root planing in non-surgical periodontitis treatment.
Detailed description
Objectives: 1. To evaluate if additional subgingival delivery of chloramine and hyaluronic acid gels would enhance clinical outcomes of scaling and root planing in periodontitis patients. 2. To assess if additional subgingival delivery of chloramine and hyaluronic acid gels would reduce total counts of periodontopathogenic bacteria compared to scaling and root planing alone. The treatment will consist of two treatment modalities: (1) Control group - full mouth scaling and root planing (SRP) (2) Test group - full mouth SRP + Perisolv+ Hyadent BG gels. The periodontal treatment will be performed in one session without time restrictions. Under local anesthesia, an experienced operator, will perform a full mouth subgingival scaling and root planing with an ultrasonic device and Gracey curettes. Afterwards, all teeth will be polished using a low-abrasive paste. Teeth in the test group (all teeth with PD ≥ 5 mm) will adjunctively be treated with chloramine gel (Perisolv), which will be inserted into periodontal pockets before and during SRP (2 times). The nozzle will be placed in the pocket mesially, lingually, distally and bucally. Teeth will be polished and all treated pockets will be filled with hyaluronic acid gel. Teeth in control group will receive SRP + polishing
Interventions
PROCEDUREScaling and root planing
Scaling and root planing will be accomplished with ultrasonic and hand instruments (Gracey curettes).
PROCEDUREScaling and root planing + Perisolv +Hyadent BG gels
Scaling and root planing will be accomplished with ultrasonic and hand instruments (Gracey curettes), Perisolv gel will adjectively be applied to all pockets with probing depth(PD) ≥ 5 mm, which will be inserted into periodontal pockets before and during SRP (2 times). The nozzle will be placed in the pocket mesially, lingually, distally and bucally. Afterwards, all teeth will be polished and all treated pockets will be filled with hyaluronic acid gel (Hyadent BG).
Sponsors
Lithuanian University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Periodontal examination, microbiologic sampling and professional oral cleaning will be performed by the investigator, unaware of periodontal treatment. Periodontal treatment will be performed by the investigator, unaware of clinical examination. Microbiological analysis will be performed by a third investigator, masked from clinical measurements and periodontal treatment.
Intervention model description
The treatment will consist of two treatment modalities: (1) Control group - full mouth scaling and root planing (SRP) (2) Test group - full mouth SRP + Perisolv +Hyadent BG gels.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* \> 30 years old; * Good general health according to medical history and clinical judgment; * Exhibiting at least one pocket in each quadrant with pocket depth (PD) ≥ 5 mm; * Radiographic evidence of bone loss ( \> 2 mm from cemento-enamel junction (CEJ) ); * Untreated periodontal disease; * Minimum 20 teeth (wisdom teeth excluded); * No removable prosthesis.
Exclusion criteria
* Patients already included in other clinical trials; * Periodontal treatment during the last 12 months; * Antibiotic treatment 6 months prior to the start of the trial; * Antibiotic prophylaxis required for dental treatment; * Ongoing medication that may affect the clinical features of periodontitis; * Pregnant/lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth (PD) reduction | 6 months | PD (probing depth): the distance (mm) between the gingival margin and the bottom of the sulcus/pocket |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level (CAL) | 6 months | CAL (clinical attachment level): will be calculated for each site as the sum of PD and the gingival recession/overgrowth. |
| Bleeding on probing (BOP) | 6 months | BOP (bleeding on probing): presence (+) or absence (-) of bleeding within 15s after probing the pocket (%). |
| Plaque Index (PI) | 6 months | PI (Plaque index): presence of dental plaque along the mucosal margin at 6 sites of the implant presence (+) or absence (-). |
| Reduction of total counts of periodontopathogenic bacteria | 6 months | Subgingival plaque samples will be analyzed for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia Treponema denticola and Prevotella intermedia |
Countries
Lithuania
Outcome results
None listed