Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633640
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Evaluation of an Algae-Based Biphasic Bone Graft Material and Collagen Membrane in the Treatment of Periodontal Intrabony Defects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of an Algae-Based Biphasic Bone Graft Material and Collagen Membrane in the Treatment of Periodontal Intrabony Defects A Randomized Clinical Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 eg 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 eg 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 2080 and collagen membrane in the treatment of patient with intrabony periodontal defects
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 eg 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 eg 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 2080 and collagen membrane in the treatment of patient with intrabony periodontal defects
Detailed Description:
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
Bleeding on probing BOP
Plaque index PI
Probing pocket depth PPD
Gingival recession GR
Defect depth and width
Radiographic depth and width
Postoperative care and satisfaction assessment
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
Bleeding on probing BOP
Plaque index PI
Probing pocket depth PPD
Gingival recession GR
Defect depth and width
Radiographic depth and width
Postoperative care and satisfaction assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None