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The main goal is to evaluate and compare the clinical and radiographic efficacy of autogenous demineralized dentin as bone graft substitute versus autogenous bone graft when performed with modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intrabony defects.
The main question is: In periodontitis patients with intrabony defects, will using autogenous demineralized dentin as bone graft substitute result in clinical attachment gain and linear bone fill similar to autogenous bone graft following modified minimally invasive surgical technique? After enrolment, each participant with intra-bony defects will receive the initial phase of the therapy, which will include oral hygiene instructions, supragingival and subgingival debridement using ultrasonic and hand instrumentations and relieving of occlusal trauma if any.
After 4-6 weeks, an individually customized positioning stent will be fabricated for each participant and a pre-operative periapical x-ray using parallel-angle technique will be employed using X-ray film holding system to ensure accuracy and reproducibility of the measurements.
Criteria used to indicate that surgery is required include the persistence of interproximal defect with PD (Probing depth) ≥ 5 mm, CAL (Clinical attachment loss) ≥ 4 mm.
Surgical procedures will include flap elevation for approaching the defect-associated sites using the modified minimally invasive surgical technique (M-MIST).
Intervention group: The defect will be filled with autogenous demineralized dentin graft prepared from the participant's freshly extracted own teeth.
Control group: The defect will be filled with autogenous bone graft harvested from the retromolar area.
For both groups, flaps will be approximated and sutured at the original position. All the subjects will be evaluated at 1, 3, and 6 months for clinical and radiographic parameters. Outcomes:The results of Clinical attachment level (CAL) gain, Linear bone fill, Gingival index (GI), Plaque index (PI), Probing pocket depth (PPD), Gingival recession (GR), Bleeding on probing (BoP), Postoperative pain and Patient satisfaction will be measured at baseline, 1 month, 3 months and after 6 months.
Research objective: The aim of conducting this research is the development of a newer, less invasive and cost-effective therapeutic approaches that help in management of periodontal intrabony defects. Due to the shortcomings of other bone substitute materials, another bone substitute material that would be completely autogenous and cost-effective is required. Grafting autogenous demineralized dentin has been used extensively for socket preservation and showed promising results in addition to being cost-effective.
Research Procedure in brief:
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:
Patient-related criteria:
Teeth related criteria:
II. Exclusion criteria:
Patient-related criteria:
Teeth related criteria:
General operative procedure:
Pre-surgical patient preparation (Re-evaluation phase):
Surgical procedures
The participants will be divided into two groups:
Intervention group:
• The participant's own freshly extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present) and have their crown decapitated, using a high- speed fine finishing stone and saline irrigation. The pulp chamber and root pulp will be cleaned by split opening the root and cleaning it out using a high-speed diamond bur. Subsequently, teeth will be ground, and demineralized using a hand bone mill. Then the particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid5 for 30 min then washed twice in saline and dried with sterile gauze. Then it will be used as a graft for the intra-bony defect after modified minimally invasive surgical technique.
Control group:
Post-operative care and follow-up
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autogenous Demineralized Dentin Graft | Experimental | An Autogenous Demineralized Dentin Graft will be prepared from the participant's freshly extracted teeth and placed in the intrabony defect following the modified minimally invasive surgical technique. |
|
| Autogenous bone Graft | Active Comparator | An Autogenous Bone Graft will be harvested from the retromolar area and placed in the intrabony defect following the modified minimally invasive surgical technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autogenous Demineralized Dentin Graft | Biological | The participant's own freshly extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present) and have their crown decapitated, using a high- speed fine finishing stone and saline irrigation. The pulp chamber and root pulp will be cleaned by split opening the root and cleaning it out using a high-speed diamond bur. Subsequently, teeth will be ground, and demineralized using a hand bone mill. Then the particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid5 for 30 min then washed twice in saline and dried with sterile gauze. Then it will be used as a graft for the intra-bony defect after modified minimally invasive surgical technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical attachment level (CAL) gain change from baseline to 6 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, 1 month, 3 months and 6 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 6 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. |
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Inclusion Criteria:
Patient-related criteria:
Teeth related criteria:
Exclusion Criteria:
Patient-related criteria:
Teeth related criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ghada M. Abouhussein, Bachelor | Contact | +02 01004966156 | ghada.mohammed@dentistry.cu.edu.eg | |
| Nesma Shemais, Ass Lecturer | Contact | nesma.shemais@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Ghada M. Abouhussein, Bachelor | Cairo University | Principal Investigator |
| Weam El-Battawy, Ass professor | Cairo University | Study Director |
| Nesma Shemais, Ass lecturer |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Recruiting | Cairo | Egypt |
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A non-randomized Clinical Trial
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| Autogenous Bone Graft | Biological | Modified minimally invasive surgical technique (M-MIST) will be performed in the intra-bony defects, with autogenous bone graft placement. The graft will be harvested from the retromolar area using automatic chip maker (ACM) bur and a hand bone mill will be used to grind the chips into particles, then it will be placed in the defect. |
|
| Linear bone fill will be measured at baseline, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner |
| Gingival index (GI) change from baseline to 6 months | The GI will be evaluated by using Silness-Loe GI (0 = Normal gingiva, 1 = Mild inflammation, 2 = Moderate inflammation, 3 = Severe inflammation). | GI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner |
| Plaque index (PI) change from baseline to 6 months | The PI will be evaluated by using Silness-Loe PI (0 = no plaque, 1 = thin film of plaque along the gingival margin, 2 = Moderate accumulation of plaque in the sulcus, 3 = Large amount of plaque in sulcus along the gingival margin). | PI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner |
| Probing pocket depth (PPD) change from baseline to 6 months | The PPD will be clinically measured by using UNC 15 periodontal probe from the gingival margin to the depth of the pocket. An individually customized positioning stent will be fabricated for each patient to ensure accuracy and reproducibility of the measurements. | PPD will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner. |
| Gingival recession (GR) change from baseline to 6 months | The GR will be clinically measured by using UNC 15 periodontal probe from the CEJ to the gingival margin. | GR will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner. |
| Bleeding on probing (BoP) change from baseline to 6 months | The BoP will be clinically measured by using UNC 15 periodontal probe from the CEJ to the gingival margin. | BoP will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner. |
| Postoperative Pain | Postoperative Pain will be measured by using visual analogue score (0-10). | Postoperative Pain will be measured after the surgical procedure and 2 weeks post-surgical. |
| Patient satisfaction | Patient satisfaction will be measured using a survey. | Patient satisfaction will be measured 2 weeks post-surgical. |
| Cairo University |
| Study Chair |