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The aim of the present study is to clinically and radiographically compare the effectivness of Scaling and Root Plannig (SRP) in association with lipo-curcumin gel (LC) respect SRP+ lipo-gel (L), SRP+ discharged (D) gel and SRP alone.
This study will be designed as a randomized clinical trial of 12-month duration. A total of 40 patients will be recruited and randomly equally distributed into 4 groups: an experimental group treated with SRP + LC, a first control group treated with SRP + L, a second control group treated with SRP+D and a third control group SRP alone.
Each defect will be treated with an ultrasonic scaler with dedicated thin tips for supra- and subgingival debridement associated with hand instrumentation under local anesthesia. Caution will be taken to preserve the stability of soft tissues. Following SRP, experimental and control sites will be randomly chosen. The test sites will be t filled with a Lipo-Curcumin gel and sealed with cyanoacrylate. In the first control group the defects will be be filled with a Lipo gel and sealed with cyanoacrylate. In the second control sites he pocket defect will be filled with a discharged gel and sealed with cyanoacrylate, in the third control group SRP alone will be performed.
Pre- and post-treatment clinical measurements were performed by an examiner blinded to the treatment modalities using a graded periodontal probe (HuFriedy UNC 15). Before the treatment and at 6 and 12 months post-treatment, all patients were examined by measuring the clinical attachment level, probing depth, gingival recession, full-mouth plaque score and bleeding on probing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipo-Curcumin gel + SRP | Experimental | After SRP the pocket defect will be filled with a Lipo-Curcumin gel and sealed with cyanoacrylate. |
|
| Lipo gel + SRP | Active Comparator | After SRP the pocket defect will be filled with a Lipo gel and sealed with cyanoacrylate |
|
| Discharged Gel + SRP | Active Comparator | After SRP the pocket defect will be filled with a discharged gel and sealed with cyanoacrylate |
|
| SRP alone | Active Comparator | SRP alone will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipo-Curcumin gel + SRP | Procedure | The pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of Lipo- Curcumin gel. The pocket will be sealed with cyanoacrylate. |
| Measure | Description | Time Frame |
|---|---|---|
| Pocket Probing Depth (PPD) | Distance between the gingival margin and the bottom of the pocket. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Attachment Level (CAL) | Distance between the CEJ and the bottom of the pocket | 12 months |
| Gingival Recession (GR) | Distance between the CEJ and the gingival margin. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele Paolantonio, DDS, MD | Contact | 3395204073 | michelepaolantonio@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Michele Paolantonio, DDS, MD | University 'G. D'Annunzio' of Chieti | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| G. d'Annunzio University | Recruiting | Chieti | CH | 66100 | Italy |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D010514 | Periodontal Pocket |
| D017622 | Periodontal Attachment Loss |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
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| Lipo gel + SRP | Procedure | The pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of Lipo gel. The pocket will be sealed with cyanoacrylate. |
|
| Discharged Gel + SRP | Procedure | The pocket defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of discharged gel. The pocket will be sealed with cyanoacrylate. |
|
| SRP alone | Procedure | The pocket defect will only be debrided with the use of fine ultrasound tips and mini hand instruments and no further treatment will be performed. |
|
| 12 months |
| Full Mouth Plaque Score | Index that evaluates the general presence of bacterial plaque for all teeth. Through the passage of the probe, the presence of plaque deposits is reported for 4 surfaces for each tooth. A ratio is made between the contaminated surfaces and the total surfaces investigated to obtain a percentage value. | 12 months |
| Full Mouth Bleeding Score | Index that evaluates the general presence of bleeding for all teeth. Through the insertion of a periodontal probe, the presence of bleeding on probing is signaled for 4 sites for each tooth. A ratio is made between the bleeding sites and the total sites investigated to obtain a percentage value. | 12 months |