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NCT Number: NCT06570265

RES-SAFE (Resorption, Safety, and Efficacy of Absorbable Collagen Membrane)

The clinical study aims to assess the long-term safety and efficacy of the interventional medical device. The clinical study will enrol up to 50 patients aged 18 years and older, who meet specific inclusion and exclusion criteria designed to ensure patient safety and reliable data collection.

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Key information

Conditions

Guided Bone Regeneration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(among others):

  • Patients over 18 years old (both sex) with full legal capacity who understand the treatment and sign the informed consent and who are medically healthy, except treated condition.

Exclusion criteria

(among others):

  • Patients with dental diseases or conditions (except treated condition);
  • Patients with unsatisfactory oral hygiene;
  • Patients with alcohol, substance abuse, smoking habits, known allergy to collagen;
  • Patients with severe or chronic diseases or with systemic inflammation and all patients classified as unhealthy;
  • Pregnant or breast feeding women.

Treatment and study plan

GBR membrane

Device

GBR procedure is a technique often used in conjunction with dental implants to enhance the success and stability of the implant. This technique involves using barrier membranes to protect the bone graft or defect site from the rapid proliferation of surrounding soft tissues. In this clinical investigation resorbable, collagen membrane will be used.

Primary outcomes

  1. Assessment of collagen membrane's - efficacy and safety.

    Time frame: 6 months after intervention

    Remnants of the collagen membrane, new blood vessels formation, and the absence of inflammation in histological results.

Secondary outcomes

  1. Complication rate

    Time frame: 7 days and 6 months after intervention

    Complication rate assessed as the ratio patients with any complication to all patients.

  2. Change in bone dimensions

    Time frame: Baseline, 6 and 12 months after intervention

    % change in horizontal bone dimensions at three subcrestal levels assessed via CBCT.

  3. VAS scale

    Time frame: On the day of intervention and after 1, 2, 3 days. Satisfaction - on the day of intervention.

    Scale VAS for pain, swelling, bleeding. VAS scale will be used to assess satisfaction of the intervention.

  4. Assessment of collagen membrane's - safety.

    Time frame: From the beginning till the end.

    Number of (S)AEs.

Study contacts

Contact information is provided by the study sponsor or research team.

Pure Clinical

CONTACT

[email protected]

+ 48

Sponsors and collaborators

Lead sponsor

Hyundai Bioland Co., Ltd.

Industry

Registry information

Official study title

Evaluation of Resorption, Safety, and Efficacy of Absorbable Collagen Membrane in Preventing Significant Bone Loss Following GBR (Guided Bone Regeneration) Procedure.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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