Multicentre, open label, randomised, clinical study to evaluate and compare the efficacy and safety of PerioCream, a Periodontal Paste Dressing and Gum Brushing Solution as an adjunct treatment to scaling and root planing (SRP), with SRP alone in patients suffering from chronic periodontitis.

Treatment Group: (Patients N=20) PerioCream Periodontal Paste Dressing was applied once over the gums and gingival sulcus for 2-3 hours immediately after SRP on patients suffering from chronic periodontitis. This was followed by 10 days of brushing with PerioCream Gum Brushing Solution.

Control Group: (Patients N=9) The Control Group also suffering from chronic periodontitis were treated with SRP only.

Both Treatment Group and Control Group were evaluated at Day 0, Day 5 and Day 11 following onset of the study for the following parameters:

Parameters measured during each evaluation day:

  • • Plaque Index (PI)9
  • • Gingival Index (GI)
  • • Periodontal Bleeding Index (PBI)

Bacterial count of Periodontopathogenic Bacteria:

  • • Prophyrompnas Gingivalis (Pg)
  • • Prevotella intermedoa (Pi)
  • • Aggregatibacer actinomycetemcomitans (Aa)
  • • Fusobacterium nucleatum (Fn)
 
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Clinical Trial

Multicentre, open label, randomised, clinical study to evaluate and compare the efficacy and safety of PerioCream®, a Periodontal Paste Dressing and Gum Brushing Solution as an adjunct treatment to scaling and root planing (SRP), with SRP alone in patients suffering from chronic periodontitis.

Percentage of patients

Treatment Group Control Group
Control group: 66.7% were infected at the start of the treatment. Out of these 66.7%, 100% were still infected after 11 days. Treatment group: 60% were infected at the start of the treatment. Out of these 60%, only 25% were still infected after 11 days.

Gingival Index average for group**

Treatment Group Control Group
**Gingival Index was assessed using (Loe and Silness; 1963) index system for the assessment of the gingival condition and record qualitative changes on the gingival. It scores the marginal and interproximal tissues separately on the basis of 0 to 3.

Plaque Index average for group*

Treatment Group Control Group
*Plaque levels were assessed using the Turkesy modification of the Quiglet-Hein Plaque Index.

Periodontal Bleeding Index average for group***

Treatment Group Control Group
***Periodontal Bleeding Index was measured using Muhleman and Son 1971 score chart, which described the sulcus bleeding.

Percentage of patients experiencing Halitosis Sensation reduction

Treatment Group Control Group
Percentage of patients experiencing Halitosis Sensation reduction
 
Microbial Infection Count Periodontal Bleeding Index
Plaque Index Gingival Index
Halitosis Reduction

Summary

None of the patients from the Treatment Group complained about irritation following application of the PerioCream Periodontal Paste Dressing. Between group comparisons indicate that the patients of the Treatment Group experienced significantly greater reduction in Plaque Index, Gingival Index and Periodontal Bleeding Index after 11 days. Application of the PerioCream Periodontal Paste Dressing significantly reduced the bacterial load of the gums as compared to Control Group on day 11. A total of 9 out of 11 patients (82 %) in Treatment Group were successfully cured after 11 days of treatment, whereas in Control Group, none of the patients were cured after day 11. After the PerioCream treatment, all patients experienced reduction in gum pain, dryness sensation, gum or sulcus bleeding, including symptoms of infection. In summary, the use of PerioCream treatment as an adjunct to SRP treatment is vastly beneficial for patients compared to patients receiving SRP treatment only.