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a clinical trial will be made to investigate the effect of locally applied injectable prf (iPRF) plus vitamin D on the periodontal pockets in stage III periodontitis patients
in this clinical trial, the treatment of periodontal pockets in stage III periodontitis patients will be evaluated. the study participants will be divided in 3 groups:
First group >> will be treated with professional mechanical plaque removal (PMPR) only.
second group >> will be treated with PMPR + locally applied iPRF.
Third group >> will be treated with PMPR + locally applied iPRF + vitamin D.
Then the results will be compared after 6 months of the treatment (clinically and radiographically).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PMPR only | Active Comparator | scaling and root planing only will be made for group 1 (control group) |
|
| PMPR + iPRF | Experimental | scaling and root planing plus locally applied iPRF in the periodontal pocket will be made for test group 1. |
|
| PMPR + iPRF + Vit.D | Experimental | scaling and root planing plus locally applied iPRF and vitamin D in the periodontal pocket will be made for test group 2. vitamin D will be obtained from a commercial product in the Egyptian pharmacies called (Devarol S) in the form of injectable ampoules containing 200000 IU of cholecalciferol (2.5 mg/ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PMPR+iPRF | Procedure | locally applied iPRF in the periodontal pocket |
|
| Measure | Description | Time Frame |
|---|---|---|
| pocket depth reduction | estimate the amount of reduction of the pocket depth from baseline and after 6 months of treatment | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| clinical attachment level (CAL) gain | the amount of CAL gained from baseline and after 6 months of treatment | 6 months |
| Plaque index | comparison of amount of plaque before and after treatment using plaque score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Fattouh, Bachelor | Contact | +201015013868 | ahmed.fattouh@dentistry.cu.edu.eg | |
| Prof.Dr Karim Fawzy, professor | Contact | +201005444050 | karim.fawzy@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Prof.Dr Manal Hosny, professor | Cairo University | Study Director |
| Prof.Dr Karim Fawzy, Professor | Cairo University | Study Director |
| Prof.Dr Luigi Nibali, Professor |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38153510 | Background | Torumtay Cin G, Lektemur Alpan A, Cevik O. Efficacy of injectable platelet-rich fibrin on clinical and biochemical parameters in non-surgical periodontal treatment: a split-mouth randomized controlled trial. Clin Oral Investig. 2023 Dec 28;28(1):46. doi: 10.1007/s00784-023-05447-8. |
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| ID | Term |
|---|---|
| D010514 | Periodontal Pocket |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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the masking will be applied in the two test groups where iPRF will be used and neither the principle investigator nor the participants will know if vitamin D will be applied to the iPrf or a placebo.
| PMPR+iPRF+Vit.D | Drug | locally applied iPRF plus vitamin D in the periodontal pocket |
|
|
| PMPR only | Procedure | scaling and root planing only will be done for the periodontal pocket for the control group |
|
|
| 6 months |
| Bleeding on probing (BOP) | measuring the percentage of BOP using a periodontal probe before and after treatment | 6 months |
| Gingival Marginal Level (GML) | determining the location of gingival margin in relation to the tooth before and after treatment | 6 months |
| Post-operative Pain | comparing the pain before and after treatment using Visual Analogue Scale(VAS) Questionnaire. A scale from 0-10 will be used with 0 means no pain and 10 means maximum pain. | 6 months |
| Treatment time taken for each groups | a timer will be used to determine the required time of each procedure of the 3 study groups | 6 months |
| degree of bone fill or loss | using digital software, evaluation of the radiographic changes will be done at the area diagnosed with periodontal problem and selected for the treatment before and after the intervention. | 6 months |
| King's College London |
| Study Director |
| Dr.Manar T El-zanaty, Doctorate | Cairo University | Study Director |
| Ahmed Fattouh, Bachelor | Cairo University | Principal Investigator |