Minimally Invasive Non-Surgical Technique, Periodontal Intrabony Defects, Platelet-Rich Fibrin
Conditions
Brief summary
This study aims to clinically and radiographically evaluate the adjunctive effect of injectable platelet-rich fibrin (i-PRF) used in combination with a minimally invasive non-surgical technique for the regenerative treatment of intrabony periodontal defects.
Detailed description
Periodontitis is a chronic inflammatory disease characterized by the progressive destruction of the periodontal supporting tissues, ultimately leading to tooth loss if left untreated. Optimal periodontal regeneration within intrabony defects depends on the preservation of soft tissues and the maintenance of primary wound closure. Minimally invasive non-surgical periodontal therapy (MINST) has been introduced as a concept aiming to obtain extensive subgingival debridement with minimal tissue trauma. Platelet-rich plasma (PRP) is an autologous blood product which is created through the centrifugation process of whole blood. It is defined as having a platelet concentration above that of normal physiological levels. The platelets present in PRP carry granules containing a significant number of active biomolecules.
Interventions
PROCEDUREMinimally invasive non-Surgical technique
Patients will receive minimally invasive non-Surgical technique (MINST) alone
PROCEDUREMinimally invasive non-Surgical technique + platelet-rich fibrin
Patients will receive minimally invasive non-Surgical technique (MINST)+ injectable platelet-rich fibrin (i-PRF) injection
Sponsors
October 6 University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of both genders \>18 years old, medically free of systemic diseases affecting periodontal regeneration. * Diagnosis of 'periodontitis' stage III (grades B or C). * Single-rooted and multi-rooted vital teeth in either the maxilla or the mandible. * Presence of comparable bilateral two- or three-walled intrabony defects \[probing pocket depth (PPD), \> 5 mm with intrabony defect depth ≥ 3 mm, from the alveolar crest to the defect base, at screening radiograph\] not in a furcation-involved tooth.
Exclusion criteria
* Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc. * Pregnant and lactating women * Current use of any form of tobacco. * Non-surgical periodontal treatment in the past 6 months, or surgical periodontal treatment in the past 12 months. * Degree 2 or 3 mobility of the involved sites.6. * Presence of periapical pathology, acute infection, or subgingival restoration which could interfere with clinical measurements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of comparable bilateral-walled intrabony defects | 6 months postoperatively | Assessment of intrabony defect fill radiographically will be measured using the standardized paralleling technique. Presence of comparable bilateral-walled intrabony defects (PPD, \> 5 mm with intrabony defect depth ≥ 3 mm, from the alveolar crest to the defect base, at screening radiograph) not in a furcation-involved tooth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level | 6 months postoperatively | Clinical attachment level (CAL) will be measured in millimeters from the cemento-enamel junction (CEJ) to the base of the periodontal sulcus at 6 sites per tooth |
| Interproximal probing depth | 6 months postoperatively | Probing depth (PD) will be measured in millimeters from the gingival margin to the base of the periodontal sulcus at 6 sites per tooth |
| Gingival margin | 6 months postoperatively | Gingival margin will be measured from the cemento-enamel junction (CEJ). |
| Bleeding on probing | 6 months postoperatively | Bleeding on Probing (BoP) will be measured using papillary bleeding index that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus |
| Plaque index | 6 months postoperatively | Plaque index (PI) will be measured for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin |
Countries
Egypt
Contacts
CONTACTAmir R Elngar, B.D.S
Outcome results
None listed