Periodontal Pocket
Conditions
Keywords
iPRF, vitamin D, Cholecalciferol, periodontal pocket
Brief summary
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
Detailed description
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).
Interventions
PROCEDUREPMPR+iPRF
locally applied iPRF in the periodontal pocket
DRUGPMPR+iPRF+Vit.D
locally applied iPRF plus vitamin D in the periodontal pocket
PROCEDUREPMPR only
scaling and root planing only will be done for the periodontal pocket for the control group
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients with healthy systemic condition. 2. Adult patients ˃ 18 years old. 3. Patients with Stage III periodontitis. 4. Patients accept 3-month follow-up period (cooperative patients). 5. Patients provide an informed consent.
Exclusion criteria
1. Presence of prosthetic crowns. 2. Extensive interproximal restorations. 3. Periodontal therapy within the last 12 months. 4. Having undergone surgical periodontal therapy or undergoing orthodontic treatment. 5. Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis. 6. The use of antibiotics or anti-inflammatory drugs 3-month prior to the procedure and till the end of 6-month of follow-up. 7. Smokers. 8. Pregnant females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pocket depth reduction | 6 months | estimate the amount of reduction of the pocket depth from baseline and after 6 months of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on probing (BOP) | 6 months | measuring the percentage of BOP using a periodontal probe before and after treatment |
| Gingival Marginal Level (GML) | 6 months | determining the location of gingival margin in relation to the tooth before and after treatment |
| clinical attachment level (CAL) gain | 6 months | the amount of CAL gained from baseline and after 6 months of treatment |
| Plaque index | 6 months | comparison of amount of plaque before and after treatment using plaque score |
| Treatment time taken for each groups | 6 months | a timer will be used to determine the required time of each procedure of the 3 study groups |
| degree of bone fill or loss | 6 months | 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. |
| Post-operative Pain | 6 months | 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. |
Contacts
Primary ContactAhmed Fattouh, Bachelor
Backup ContactProf.Dr Karim Fawzy, professor
Outcome results
None listed