Clinical trial NCT06633640: Evaluation of an Algae-Based Biphasic Bone Graft Material and Collagen Membrane in the Treatment of Periodontal Intrabony Defects
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Intrabony Periodontal Defect
Periodontitis
Keywords: Algae-Based Biphasic Graft substances
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Clinical attachment level (CAL)
timeFrame: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
Secondary outcomes:
measure: Probing pocket depth (PPD)
timeFrame: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
Other outcomes:
measure: Bleeding on probing (BOP)
timeFrame: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
measure: Plaque index (PI)
timeFrame: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
measure: Gingival recession (GR)
timeFrame: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
measure: Depth and width of defect (including Radiographic)
timeFrame: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
measure: Postoperative care and satisfaction assessment
timeFrame: From date of enrolment until the date of first documented progression i.e.at least12 months after the last enrolment.
Locations:
city: Cairo
country: Egypt
facility: Periodontology Clinic, Faculty of Oral and Dental medicine, University of Cairo, Egypt.
Study officials:
References:
citation: 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.