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In light of the controversy that are already approved but that however still exists regarding the efficacy and influence the management of Periodontitis, the aim of this study was to evaluates, at 6-months follow-up, the post-treatment clinical and serum parameters in patients with periodontitis, treated by either Full Mouth Scaling and Root Planing (FM-SRP) treatment versus conventional oral hygiene treatment on serum CRP and Growth differentiation factor-15 levels.
This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2016. The local ethical committee approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent.
Subjects with a diagnosis of periodontitis were enrolled in this clinical trial. The inclusion criteria were: 1) good condition of general health, 2) a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm, 3) no involvement of the furcation, 4) a minimum of six teeth per quadrant, respectively. The exclusion criteria were: 1) periodontal therapy during the last 12 months, 2) assumption of antibiotics during the last 6 months, 3) pregnancy, 4) any systemic condition which might affect the effects of the study treatment, 5) previous or current radiation or immunosuppressive therapies, 5) use of mouthwash containing antimicrobials during the previous 3 months, 6) no use of hormonal contraceptives, 7) medication by anti-inflammatory and immunosuppressive drugs, 8) previous history of hard-drinking, 9) smoking, 10) class II and III tooth mobility. Patients randomly undergo to full mouth SRP or Quadrant SRP
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periodontitis quadrant Scaling root planing (SRP) | Placebo Comparator | Each selected subject underwent to quadrant SRP |
|
| Periodontitis full mouth scaling root planing (SRP) | Active Comparator | Each selected subject underwent to full mouth SRP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full mouth Scaling and root planing | Other | patients were treated with full mouth Scaling and root planing |
|
| Measure | Description | Time Frame |
|---|---|---|
| reduction of Growth differentiation factor-15 serum levels | evaluation of serum Growth differentiation factor-15 change | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaetano Isola | University of Catania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Policlinico G. Rodolico | Catania | 95124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37605193 | Derived | Isola G, Tartaglia GM, Santonocito S, Chaurasia A, Marya A, Lo Giudice A. Growth differentiation factor-15 and circulating biomarkers as predictors of periodontal treatment effects in patients with periodontitis: a randomized-controlled clinical trial. BMC Oral Health. 2023 Aug 21;23(1):582. doi: 10.1186/s12903-023-03237-y. |
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Study results
6 months
Pubmed or internet
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
| D010517 | Periodontics |
| D003813 | Dentistry |
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Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Quadrant Scaling and Root Planing (SRP) or Full-Mouth Scaling and Root Planing
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Sealed envelopes
| Quadrant Scaling and root planing | Other | patients were treated with quadrant Scaling and root planing |
|
| D013357 |
| Subgingival Curettage |
| D011313 | Preventive Dentistry |