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Periodontal diseases are one of the most prevalent chronic diseases involving a spectrum of inflammatory conditions. Intrabony defects, also known "vertical defects," are specific osseous and morphological defects and one of the consequences and end result of periodontitis. Intrabony defects are particularly associated with periodontal progression however certain patient-related factors play important role in its management such as plaque management, smoking, medical history, tooth mobility and endodontic condition.
Periodontal repair is aimed to gain periodontal attachment using various modalities in severely compromised teeth, decrease pocket depth, and stabilize gingival recession. Different types of biomaterial substitutes and bone graft materials are available, but the choice of suitable "golden" type or technique is difficult and dependent on various factors particularly anatomical variations, cost effective, clinical situations, the systemic general condition, operation site, socioeconomic conditions and the surgeon choice.
The current therapeutic options mainly focus on minimize symptoms and prevent disease progression but are not able to fully restore damaged bone and periodontal supporting tissues. Many of these regenerative approaches, (e.g. bone grafts) provided variable and unpredictable clinical outcomes. Therefore, it is imperative to develop alternative regenerative strategies.
There is necessity to introduce novel and alternative materials of natural and synthetic origins for bone grafting use in dental field. This requires well performed clinical trials on humans to understand the effects of such materials (e.g the marine algae-based substitutes and biodegradable (absorbable) materials) either as a single or combined formula.
The aim of the current clinical study is to evaluate the clinical efficacy of an algae-based biphasic bone graft material (AlgOss 20/80) and collagen membrane in the treatment of patient with intrabony periodontal defects.
Study population Recruited patients attending the dental clinic at the faculty of dentistry of the University of Cairo, Egypt will be included following the study eligibility criteria.
Population: Patients with periodontal intrabony defects (Stage III and IV periodontitis).
Intervention: Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane.
Control: Conventional flap with collagen membrane.
Outcomes:
Primary outcome:
- Clinical attachment level (CAL)
Secondary outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane |
|
| Control group | No Intervention | Conventional flap with collagen membrane |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane. | Combination Product | The graft material will be prepared following the manufacturer instruction, transferred into a sterile cup than the mixture is condensed without overfilling in the intrabony defect to the level of the surrounding bony walls. The filled site will be than covered with collagen membrane. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical attachment level (CAL) | The CAL will be measured from the cementoenamel junction (CEJ) to the base of the sulcus or pocket | From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment. |
| Measure | Description | Time Frame |
|---|---|---|
| Probing pocket depth (PPD) | Probing pocket depth (PPD): PPD is determined by measuring the distance from the gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe. | From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment. |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on probing (BOP) | The BOP is the primary parameters to assess gingivitis and recorded using gingival index (GI) score. The GI and gingival bleeding caused by running a Williams periodontal probe inside the pocket on the mesial, distal, buccal, and palatal surfaces of all teeth will be evaluated following. The GI of each individual will be determined by calculating the values determined for each tooth and obtaining the averages. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Periodontology Clinic, Faculty of Oral and Dental medicine, University of Cairo, Egypt. | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11895280 | Background | Paolantonio M. Combined periodontal regenerative technique in human intrabony defects by collagen membranes and anorganic bovine bone. A controlled clinical study. J Periodontol. 2002 Feb;73(2):158-66. doi: 10.1902/jop.2002.73.2.158. |
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| From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment. |
| Plaque index (PI) | The PI will be evaluated by probing the mesial, distal, buccal, and palatal surfaces of all teeth using a Williams periodontal probe. The PI of each individual will be determined by summing the values obtained for each tooth and calculating the averages. | From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment. |
| Gingival recession (GR) | GR is usually recorded as a clinical measure when assessing regenerative outcome as indicators of level of tissue coverage as well as new attachment. It is measured from the CEJ to the most apical extension of the gingival margin using periodontal probe at six sites per tooth. | From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment. |
| Depth and width of defect (including Radiographic) | Defect depth will be measured as the distance between the alveolar bone crest and the most apical extension of the bone defect. The width of defect will be measured as the horizontal distance between the alveolar bone crest at the intrabony defect in the direction towards the center of the tooth. Radiographic outcomes at base line, 6 ad 12 months will be measured using ImageJ software. | From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment. |
| Postoperative care and satisfaction assessment | Patients will be followed up for assessment of their satisfaction using a rating scale from 0 (no pain) to 10 (extremely severe pain) . | From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment. |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C483718 | Algipore |
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