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

October 8, 2024 updated by: Rahma Omar B. Ahmed, Cairo University

Evaluation of an Algae-Based Biphasic Bone Graft Material and Collagen Membrane in the Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Conventional flap with algae-based substitute (AlgOss) combined with collagen membrane
Combination product: 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.
No Intervention: Control group
Conventional flap with collagen membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical attachment level (CAL)
Time Frame: 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
From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing pocket depth (PPD)
Time Frame: 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.
From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on probing (BOP)
Time Frame: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
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.
From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
Plaque index (PI)
Time Frame: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
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)
Time Frame: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
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)
Time Frame: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
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
Time Frame: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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