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

Early Phase 1

• Conditions: Intrabony Periodontal Defect; Periodontitis

• Registration Number: NCT06633640
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2024-08-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical attachment level (CAL)	From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.	The CAL will be measured from the cementoenamel junction (CEJ) to the base of the sulcus or pocket

Secondary Outcome Measures

Name	Time	Method
Probing pocket depth (PPD)	From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.	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.

Trial Locations

Locations (1)

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