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

NCT06633640 | Enrolling By Invitation Early Phase 1

• 1 other identifier: 18224
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrabony Periodontal Defect; Periodontitis

Keywords

Algae-Based Biphasic Graft substances

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Probing pocket depth (PPD)

  From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.

Other Outcomes (5)

• Bleeding on probing (BOP)

  From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.

• Plaque index (PI)

  From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.

• Gingival recession (GR)

  From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.

Study Arms (2)

Intervention

EXPERIMENTAL

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

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

Control group

NO INTERVENTION

Conventional flap with collagen membrane

Interventions

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.

Intervention

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age is between ≥ 20 to ≤ 65 years old.
• Presence of intrabony defect
• Systematically free.
• The subjects understand the purpose of the study, adhere to the study protocol and given consent to be included in the study.
• Adequate plaque control and stable periodontal status (full-mouth bleeding score on probing: \<25%, and full- mouth plaque score: \<25%)

You may not qualify if:

• Smokers
• Any infection particularly at the intervention site.
• Teeth mobility more than grade 1.
• Pregnant or lactating women.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Cairo, Egypt

Location

Related Publications (1)

• 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.

  PMID: 11895280 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Interventions

Algipore

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 9, 2024
• Study Start: August 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)