Effectiveness of Hyaluronic Acid (hyaDENT BG® Gel) Compared With Enamel Matrix Proteins (Emdogain®) in the Treatment of Angular Bone Defects in Combination With a Xenograft (Bio-Oss Collagen®)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2025-01-10

Brief Summary

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The goal of this clinical trial is to learn whether hyaluronic acid (HyaDent® BG) provides similar benefits to Emdogain® when both are used with Bio-Oss® Collagen during periodontal surgery in adults with periodontal (intrabony) defects. The main questions it aims to answer are:

Does the treatment reduce probing pocket depth?

Does the treatment increase clinical attachment level?

Does the treatment increase radiographic bone fill?

Does the treatment change the gingival margin position?

Researchers will compare Bio-Oss Collagen + HyaDent BG with Bio-Oss Collagen + Emdogain to see whether HyaDent BG achieves similar improvements in clinical and radiographic outcomes as Emdogain.

Participants will:

Undergo periodontal surgery to treat the vertical bone defect(s), with either Bio-Oss Collagen + HyaDent BG or Bio-Oss Collagen + Emdogain.

Attend follow-up visits for periodontal measurements and radiographs.

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Detailed Description

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Conditions

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Periodontitis Intrabony Periodontal Defect Periodontal Bone Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bio-Oss Collagen + HyaDent BG

Periodontal regenerative treatment in which intrabony defects are treated with Bio-Oss® Collagen combined with HyaDent® BG (cross-linked hyaluronic acid gel). The procedure follows standard periodontal surgical protocols.

Group Type EXPERIMENTAL

Bio-Oss Collagen + HyaDent BG

Intervention Type BIOLOGICAL

Application of Bio-Oss® Collagen combined with HyaDent® BG (cross-linked hyaluronic acid gel) during periodontal surgery for intrabony defects. Standard regenerative protocols are followed.

Bio-Oss Collagen + Emdogain

Periodontal regenerative treatment in which intrabony defects are treated with Bio-Oss® Collagen combined with Emdogain®. The procedure follows standard periodontal surgical protocols.

Group Type ACTIVE_COMPARATOR

Bio-Oss Collagen + Emdogain

Intervention Type BIOLOGICAL

Application of Bio-Oss® Collagen combined with Emdogain during periodontal surgery for intrabony defects. Standard regenerative protocols are followed.

Interventions

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Bio-Oss Collagen + HyaDent BG

Application of Bio-Oss® Collagen combined with HyaDent® BG (cross-linked hyaluronic acid gel) during periodontal surgery for intrabony defects. Standard regenerative protocols are followed.

Intervention Type BIOLOGICAL

Bio-Oss Collagen + Emdogain

Application of Bio-Oss® Collagen combined with Emdogain during periodontal surgery for intrabony defects. Standard regenerative protocols are followed.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adults over the age of 18 diagnosed with periodontal disease-Stage III or IV periodontitis;

* Sites with bone defects and a probing pocket depth (PPD) ≥ 6 mm, accompa-nied by bleeding on probing (BoP) at re-evaluation, conducted six weeks after non-surgical periodontal therapy;
* Full Mouth Plaque Score (FMPS) \< 20% and Full Mouth Bleeding Score (FMBS) \< 15% prior to surgical treatment;
* Good general health with no systemic conditions and no known allergies to materials or medications used in the study.

Exclusion Criteria

* Medical conditions contraindicating surgical intervention;

* Pregnancy or lactation;
* Heavy smokers;
* Untreated periodontal disease;
* Poor oral hygiene;
* Acute infectious lesions in the area of intervention;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No