Clinical and Patient-centered Outcomes After Minimally Invasive Non-surgical Therapy for the Treatment of Splinted Stage IV Periodontitis - Randomized Controlled Clinical Trial
| Registry | NCT06772506 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 40 (Actual) |
| Sponsor | Minia University (Other) |
| Conditions | Periodontitis, Stage IV Periodontitis, Minimally Invasive Treatment, Splints |
| Interventions | Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%), Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splint (Procedure) |
| Dates | start 2022-08-11, primary completion 2024-11-11, completion 2024-11-30, first posted 2025-01-13, last updated 2025-01-14 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Periodontitis All trials for Stage IV Periodontitis All trials of Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) All trials of Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splint
Conventional periodontal treatment typically involves a combination of non-surgical and surgical approaches, such as scaling and root planing, followed by flap surgery and guided tissue regeneration. While these methods have demonstrated some success in managing periodontal disease, the low success rate in complex cases has prompted the exploration of alternative treatment modalities. One such approach is minimally invasive, non-surgical monotherapy, which aims to address the etiological source of the inflammation without the need for invasive surgical intervention.
Guided tissue regeneration, a well-established technique in periodontal treatment, employs physical barrier membranes to exclude the proliferation of unwanted gingival fibroblasts and allow the regeneration of tooth-supporting structures such as the alveolar bone, periodontal ligament, and cementum.
Recent advancements in dental therapies have led to the exploration of minimally invasive non-surgical approaches that aim to achieve comparable outcomes with reduced morbidity. This protocol outlines a randomized clinical trial to evaluate the efficacy and safety of a minimally invasive non-surgical monotherapy in treating patients with stage 4 periodontitis.
Is minimally invasive non-surgical technique more effective in reducing tooth mobility and improving clinical parameters than conventional non-surgical technique?
Periodontitis is a chronic inflammatory disease that affects the supporting structures of the teeth, including the gingiva, periodontal ligament, cementum, and alveolar bone. The advanced stages of periodontitis, such as stage 4, are characterized by severe tissue destruction, deepened pocket depths, and alveolar bone loss, which can ultimately lead to tooth mobility, drifting, and loss. Effective therapeutic interventions are necessary to halt the progression of the disease and potentially regenerate the lost periodontal tissues.
Conventional periodontal treatment typically involves a combination of non-surgical and surgical approaches, such as scaling and root planing, followed by flap surgery and guided tissue regeneration. While these methods have demonstrated some success in managing periodontal disease, the low success rate in complex cases has prompted the exploration of alternative treatment modalities. One such approach is minimally invasive, non-surgical monotherapy, which aims to address the etiological source of the inflammation without the need for invasive surgical intervention.
Guided tissue regeneration, a well-established technique in periodontal treatment, employs physical barrier membranes to exclude the proliferation of unwanted gingival fibroblasts and allow the regeneration of tooth-supporting structures such as the alveolar bone, periodontal ligament, and cementum.
Recent advancements in dental therapies have led to the exploration of minimally invasive non-surgical approaches that aim to achieve comparable outcomes with reduced morbidity. This protocol outlines a randomized clinical trial to evaluate the efficacy and safety of a minimally invasive non-surgical monotherapy in treating patients with stage 4 periodontitis.
Is minimally invasive non-surgical technique more effective in reducing tooth mobility and improving clinical parameters than conventional non-surgical technique?
| Arm | Type | Interventions | Description |
|---|---|---|---|
| conventional periodontal treatment with ultrasonic device and manual instruments | Experimental | Procedure: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) | conventional non-surgical techniques with ultrasonic and manual scaler instruments |
| Placebo minimally invasive non surgical technique with mini five and after five instruments | Placebo comparator | Procedure: Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splint | and minimally invasive non-surgical technique using mini five and after five instruments+ ultrasonic device for supragingival instrumentation |
Sex: All, ages: 18 Years to 55 Years
Inclusion Criteria: * periodontitis stage III and IV * Mobility grade 2 * age from 18-55 years * medically free * nonsmoker * Single-rooted teeth Exclusion Criteria: * Medically compromised patient * smokers * Bad oral hygiene * Non-surgical or surgical periodontal treatment in the past 12months. * Prolonged treatment with antibiotics or anti-inflammatory agents within 6months before periodontal therapy.
| Facility | City | Country | Status |
|---|---|---|---|
| Egypt | Cairo, Beni Suweif Governorate | Egypt |
NIH grants: 2019