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| Name | Class |
|---|---|
| Ondine Research Laboratories | INDUSTRY |
| Spanish Society of Periodontology and Osseointegration ( SEPA) | UNKNOWN |
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The goal of this study is to determine if patients with chronic periodontitis when undergoing with scaling and root planing (SRP) plus photodynamic therapy in comparison with SRP alone result in improved clinical, microbiological and biochemical outcomes.
This research is orientated to find an effective way to kill oral microorganisms that cause periodontitis and gingivitis with no problems of resistance, as it happens when we use antibiotics. The efficacy of this low power laser has been demonstrated in numerous fields in medicine and have been use it for years. The application of the photodynamic therapy is easy since we only have to fill the periodontal pocket with the photosensitive agent and apply the low power laser in that area. The photosensitive agent stain the bacteria immediately and the laser disrupts its membrane by a free-radical reaction. Improving the health status of the patients in a few weeks after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antimicrobial photodynamic therapy | Experimental | Antimicrobial photodynamic therapy and scaling and root planing |
|
| scaling and root planing | Active Comparator | Only scaling and root planing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antimicrobial photodynamic therapy (Periowave) and scaling and root planing | Device | ROOT PLANNING PROCEDURE: The procedure is the same as in the control group APPLICATION PROCEDURES OF THE PHOTOSENSITIZING AGENT : The photosensitive agent : Formulation Periowave Treatment Kit-2ml
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Clinical Attachment Level | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Periodontal Pocket Depth | 6 months | |
| Improvement in Bleeding on Probing | 6 months | |
| Levels of IL-1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alpiste Francisco, Professor | Contact | 963983136 | 011 34 | francisco.alpiste@uv.es |
| Name | Affiliation | Role |
|---|---|---|
| Alpiste Illueca Francisco, Professor | University of Valencia | Principal Investigator |
| Segarra vidal marta, postgraduate | University of Valencia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Valencia | Recruiting | Valencia | Valencia | 46010 | Spain |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 17, 2016 | |
| Reset | Feb 12, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 17, 2016 | Feb 12, 2016 |
| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D016745 | Root Planing |
| D014080 | Tooth Exfoliation |
| ID | Term |
|---|---|
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
| D010517 | Periodontics |
| D003813 | Dentistry |
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|
|
| scaling and root planing | Procedure | ROOT PLANNING PROCEDURE: An unique operator ( independent from the explorer) will do the root planing for both the test and control group. Every procedure will be done under local anaesthesia: Ultracain with Epinephrine 40/0,01 mg/ml. NORMON. It will be done a first session of root planning in the first and forth quadrant and in a 48 hours the root planning of the second and the third quadrant will be done. Every session wil be done with this material: Ultrasonic: Satelec suprasson p5 with ultrasonic tip H3, manual scalers: HU-FRIEDY 1/2, 7/8, 11/12, 13/14, 13/14 columbia. * The session will finish as soon as the operator have removed all the supragingival and subgingival calculus and plaque. |
|
| 6 months. |
| levels of IL-6 | 6 months |
| Levels of FNT-alfa | 6 months |
| Levels of RANKL-OPJ. | 6 months |
| López Roldán Andrés, Professor |
| University of Valencia |
| Study Chair |
| Puchades Rufino Juan, professor | University of Valencia | Study Chair |
| gil loscos francisco, professor | University of Valencia | Study Chair |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013357 |
| Subgingival Curettage |
| D011313 | Preventive Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |