Clinical trial NCT05423535: Hemostatic Gelatin Sponge Versus Collagen Matrix in Alveolar Ridge Preservation
Official title: A Randomized Controlled Trial Comparing Hemostatic Gelatin Sponge to Collagen Matrix as Socket Seal in Alveolar Ridge Preservation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Changes in Soft Tissue Height
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in soft tissue height at the buccal and lingual aspect
timeFrame: T0 (immediately post-op) and T3 (4 months)
Secondary outcomes:
measure: Wound healing
timeFrame: T1 (1 week), T2 (3 weeks) and T3 (4 months)
measure: Wound dimension
timeFrame: T0 (immediately post-op), T1 (1 week) and T3 (4 months)
measure: Changes in buccal soft tissue profile
timeFrame: T0 (immediately post-op) and T3 (4 months)
measure: Mucosal scarring
timeFrame: T3 (4 months)
Other outcomes:
Locations:
city: Geraardsbergen
country: Belgium
facility: BV Paro Glibert
state: Oost-Vlaanderen
city: Zottegem
country: Belgium
facility: Centrum voor Parodontologie en Orale Implantologie
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Jan Cosyn, Professor
role: PRINCIPAL_INVESTIGATOR
References: