Evaluation of an Algae-Based Biphasic Bone Graft Material and Collagen Membrane in the Treatment of Periodontal Intrabony Defects

NCT ID: NCT06633640

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-07-31

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, (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.

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

Conditions

Intrabony Periodontal Defect; Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention

Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane

Group Type: EXPERIMENTAL

Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane.

Intervention Type: 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.

Control group

Conventional flap with collagen membrane

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane.

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. The age is between ≥ 20 to ≤ 65 years old.

2. Presence of intrabony defect

3. Systematically free.

4. The subjects understand the purpose of the study, adhere to the study protocol and given consent to be included in the study.

5. Adequate plaque control and stable periodontal status (full-mouth bleeding score on probing: <25%, and full- mouth plaque score: <25%)

Exclusion Criteria

1. Smokers

2. Any infection particularly at the intervention site.

3. Teeth mobility more than grade 1.

4. Pregnant or lactating women.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Rahma Omar B. Ahmed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Periodontology Clinic, Faculty of Oral and Dental medicine, University of Cairo, Egypt.

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 11895280 (View on PubMed)

Other Identifiers

18224

Identifier Type: -

Identifier Source: org_study_id