Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this Clinical trial is to evaluate the clinical and radiographic outcomes of using entire papilla preservation technique with and without autogenous bone and injectable platelet rich fibrin in treatment of isolated Intrabony defects in patients with stage III periodontitis.
Research objective: The aim of conducting this research is the development of a newer, less invasive and cost-effective surgical approaches that help in treatment of periodontal intrabony defects.Due to the shortcomings of access flap approaches , another minimally invasive surgical technique which is the Entire papilla preservation technique will be used to approach the defect .Also, due to the short comings of using other bone substitute materials and resorbable membranes , the Autogenous bone graft which is the gold standard of bone grafts and the injectable platelet rich fibrin will be used in this study .
Research Procedure in brief:
The study is to be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry - Cairo University, Egypt. This study will be carried out on patients enrolled from the Outpatient Clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Cairo University.
Eligibility criteria:
I. Inclusion criteria:
II. Exclusion criteria:
General operative procedures:
1.Preoperative preparation:
Clinical examination:
Each patient will be examined to confirm that he/she met the eligibility criteria. This is followed by:
Each patient will be prescribed a 0.2% chlorhexidine-based mouthwash, twice a day, for two weeks. Clinical photographs: Clinical photographs will be taken at baseline and at 12 months postoperatively. Radiographic examination: Periapical radiographs using paralleling technique using KCP film holder will be performed for each patient on the defect site to evaluate alveolar bone loss using DIGORA system.
Initial Therapy:
The initial therapy will consist of periodontal treatment (phase I therapy) including supra gingival scaling, subgingival debridement if needed, adjustment of faulty restoration and polishing. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques.
Re-evaluation phase:
Surgical procedures
The participants will be divided into two groups:
Intervention group:
Control group:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Procedure:Entire papilla preservation technique with autogenous bone and injectable platelet rich fibrin |
|
| Control group | Active Comparator | Procedure: Entire papilla preservation technique alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entire papilla preservation technique | Other | Minimally invasive periodontal surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical attachment level (CAL) gain change from baseline to 12 months | The CAL will be clinically measured using UNC 15 periodontal probe from the cemento-enamel junction (CEJ) to the depth of defect. An individually customized positioning stent will be fabricated for each patient to ensure accuracy and reproducibility of the measurements. | CAL gain will be taken at baseline, 3 month, 6 months and 12 months after the intervention during the follow-up period and will be done by a single calibrated examiner.] |
| Measure | Description | Time Frame |
|---|---|---|
| Linear bone fill change from baseline to 12 months | Linear bone fill will be radiographically measured from the CEJ to the deepest part of the intrabony defect using the linear measurement tool of the Digora software. Individually customized positioning stent will be fabricated for each patient and parallel-angle technique will be employed using X-ray film holding system. This will ensure accuracy and reproducibility of the measurements. Radiographic linear defect depth (RLDD) will be measured as the depth of the intrabony defect from the alveolar crest to the defect base at baseline and 6 months postoperatively. The defect angle will be measured at baseline, as the angle formed between intersections of lines from the alveolar crest to the defect base and tooth long axis line. Calculation of bone fill in mm will be done by a subtraction of follow-up from baseline RLDD values, and percentages of bone fill will be expressed as the proportion of change to baseline RLDD. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laila T Sedeek, Bachelor | Contact | 01223685495 | laila.taher@dentistry.cu.edu.eg | |
| Nesma M Shemais, Ass Lecturer | Contact | nesma.shemais@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Laila T Sedeek, Bachelor | Cairo University | Principal Investigator |
| Manal M Hosny, Professor | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry, Cairo University | Recruiting | Cairo | 3753450 | Egypt |
Not provided
Not provided
Not provided
Not provided
Blinding of the operator and patient is not applicable.
- Outcome assessor (primary and secondary outcomes) & biostatistician will be blinded
| Linear bone fill will be measured at baseline, 6 months and 12 months after the intervention during the follow-up period and will be done by a single calibrated examiner] |