Hemostatic Gelatin Sponge Versus Collagen Matrix in Alveolar Ridge Preservation

April 6, 2023 updated by: University Ghent

A Randomized Controlled Trial Comparing Hemostatic Gelatin Sponge to Collagen Matrix as Socket Seal in Alveolar Ridge Preservation

Patients in need of extraction of two teeth followed by implant replacement, with > 50% buccal bone present following tooth extraction and with 1 or 2 neighbouring teeth present, were invited to participate in an intra-subject RCT comparing hemostatic gelatin sponge to collagen matrix as socket seal in alveolar ridge preservation.

The sample size calculation indicated 16 patients to be included per group. To compensate for dropouts, this number was increased to 20 patients per group. Coincidence (coin flip) determined which site is treated with the gelatine sponge and which with the collagen matrix.

Teeth were extracted without flap elevation. When deemed necessary by the clinician, papillary incisions were made for minimal reflection, which enabled to place elevators without damaging soft tissues. Buccal soft tissues were never raised. Following wound debridement and rinsing, the alveolar socket was filled with collagen-enriched deproteinized bovine bone mineral (C-DBBM, Bio-Oss Collagen® 100 mg or 250 mg, Geistlich Pharma AG, Wolhusen, Switzerland) up to the level of the oral bone crest. Subsequently, a collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland) or gelatin spons (Spongostan Dental® 1x1x1 cm, Ethicon, Johnson & Johnson, New Brunswick, VS) was sutured on top with 4 to 6 single sutures (Seralon 6/0, Serag Weissner, Naila, Germany) to protect the underlying C-DBBM.

Changes in soft tissue height at the buccal and oral aspect is the primary outcome. A small-field low-dose CBCT image was taken at T0 (immediately postop) and T3 (4 months). Those images were superimposed in specialized software (OnDemand3D, Cybermed Inc., Seoul, South-Korea). Changes in soft tissue height were calculated by subtracting soft tissue height at T3 from soft tissue height at T0.

Secondary outcomes included wound healing and closure in the first three weeks, changes in hard and soft tissues and mucosal scarring after 4 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Geraardsbergen, Oost-Vlaanderen, Belgium, 9570
        • BV Paro Glibert
      • Zottegem, Oost-Vlaanderen, Belgium, 9620
        • Centrum voor Parodontologie en Orale Implantologie

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • good oral hygiene (plaque score < 25%)
  • 1 or 2 neighbouring teeth present
  • in need for extraction of two teeth, followed by implant placement
  • >50% bone present
  • signed informed consent

Exclusion Criteria:

  • systematic diseases
  • smoking
  • history of periodontitis
  • untreated caries lesions
  • pregnancy

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group: Collagen Matrix
collagen matrix: Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland
Device: test group: collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland)
Following tooth extraction and wound debridement, the alveolar socket was filled with collagen-enriched deproteinized bovine bone mineral (C-DBBM, Bio-Oss Collagen® 100 mg or 250 mg, Geistlich Pharma AG, Wolhusen, Switzerland) up to the level of the oral bone crest. Subsequently, a collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland) or gelatin spons (Spongostan Dental® 1x1x1 cm, Ethicon, Johnson & Johnson, New Brunswick, VS) was sutured on top with 4 to 6 single sutures (Seralon 6/0, Serag Weissner, Naila, Germany) to protect the underlying C-DBBM.
Other Names:
  • control group: gelatin spons (Spongostan Dental® 1x1x1 cm, Ethicon, Johnson & Johnson, New Brunswick, VS)
Experimental: Test group: Hemostatic Gelatin Sponge
Hemostatic gelatin spons: Spongostan Dental® 1x1x1 cm, Ethicon, Johnson & Johnson, New Brunswick, VS
Device: test group: collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland)
Following tooth extraction and wound debridement, the alveolar socket was filled with collagen-enriched deproteinized bovine bone mineral (C-DBBM, Bio-Oss Collagen® 100 mg or 250 mg, Geistlich Pharma AG, Wolhusen, Switzerland) up to the level of the oral bone crest. Subsequently, a collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland) or gelatin spons (Spongostan Dental® 1x1x1 cm, Ethicon, Johnson & Johnson, New Brunswick, VS) was sutured on top with 4 to 6 single sutures (Seralon 6/0, Serag Weissner, Naila, Germany) to protect the underlying C-DBBM.
Other Names:
  • control group: gelatin spons (Spongostan Dental® 1x1x1 cm, Ethicon, Johnson & Johnson, New Brunswick, VS)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in soft tissue height at the buccal and lingual aspect
Time Frame: T0 (immediately post-op) and T3 (4 months)
A CBCT was taken at T0 (immediately post-op) and T3 (4 months). Since soft tissues were separated from hard tissues by using lip retractors and a backward position of the tongue, soft tissue height could be assessed on CBCT images. Changes in soft tissue height were calculated by subtracting soft tissue height at T3 from soft tissue height at T0.
T0 (immediately post-op) and T3 (4 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Wound healing
Time Frame: T1 (1 week), T2 (3 weeks) and T3 (4 months)

Socket wound healing score (SWHS). SWHS was assessed on the basis of occlusal clinical pictures and results in the following scores: 0 = Wound covered with keratinized gingiva, pink tissue color, no bleeding, continuous with healthy tissue; 1 = Socket filled with organized granulation tissue, no bleeding, collapsed to a depth of 0 - 2 mm from the buccal gingival margin; 2 = Socket filled with organized granulation tissue, ¼ to ½ of the wound showing red tissue color, no bleeding, collapsed to a depth of 2 - 4 mm from the buccal gingival margin; 3 = Socket filled with unorganized granulation tissue, more than ½ of the wound showing red tissue color, bleeding, no evidence of acute infection; 4 = Socket is filled with foreign material (food, etc.) and shows signs of alveolitis.

The higher the score, the worser the outcome.
T1 (1 week), T2 (3 weeks) and T3 (4 months)
Wound dimension
Time Frame: T0 (immediately post-op), T1 (1 week) and T3 (4 months)
Bucco-lingual and mesio-distal wound dimensions were registered with a periodontal probe to the nearest 0.5 mm at T0 (immediately postop), T1 (1 week) and T3 (4 months).
T0 (immediately post-op), T1 (1 week) and T3 (4 months)
Changes in buccal soft tissue profile
Time Frame: T0 (immediately post-op) and T3 (4 months)
An intra-oral scan was taken at T0 (immediately postop) and T3 (4 months). The obtained digital surface models in STL format were imported into designated software to analyze profilometric changes. A study-relevant area of interest (AOI) at the buccal aspect was selected for each site. The AOI varied between sites due to individual anatomic differences but was kept constant in each site across timepoints. Digital surface models were superimposing using the best-fit algorithm at the unchanged adjacent tooth surfaces. A mean volumetric change (mm3) within the AOI for each site from T0 to T3 was calculated by the software and divided by the AOI resulting in a mean change in buccal soft tissue profile. Details on the method can be found in an earlier paper (Eeckhout et al., 2020).
T0 (immediately post-op) and T3 (4 months)
Mucosal scarring
Time Frame: T3 (4 months)

The Mucosal Scarring Index (MSI) (Wessels et al., 2019) was registered on the basis of frontal and occlusal clinical pictures. The MSI results in a score from 0 (no scar) to 10 (most extreme scar).

The higher the score, the worser the outcome.
T3 (4 months)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Ghent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan Cosyn, Professor, University Ghent

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BC-11345

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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