Hemostatic Gelatin Sponge Versus Collagen Matrix in Alveolar Ridge Preservation

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-06

Study Completion Date

2023-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Changes in Soft Tissue Height

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intra-subject RCT with 2 treatment arms (control group: collagen matrix; test group: hemostatic gelatine sponge). In every patient two teeth are extracted. Coincidence (coin flip) will determine which site is treated with the gelatine sponge and which with the collagen matrix.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

It concerns a surgical intervention. Hence, the treating surgeon cannot be masked. As each patient receives both the control and test treatment at the same moment, the patient is masked. The investigators and outcome assessors are masked.

Study Groups

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Control group: Collagen Matrix

collagen matrix: Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland

Group Type ACTIVE_COMPARATOR

test group: collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland)

Intervention Type DEVICE

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.

Test group: Hemostatic Gelatin Sponge

Hemostatic gelatin spons: Spongostan Dental® 1x1x1 cm, Ethicon, Johnson \& Johnson, New Brunswick, VS

Group Type EXPERIMENTAL

test group: collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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control group: gelatin spons (Spongostan Dental® 1x1x1 cm, Ethicon, Johnson & Johnson, New Brunswick, VS)

Eligibility Criteria

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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