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| Name | Class |
|---|---|
| Valeant Pharmaceuticals | INDUSTRY |
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Two different surgical protocols for socket preservation were compared. Soft and hard tissue outcomes were measured clinically and radiographically at baseline and six months post operatively.
The effect of different surgical techniques for socket preservation on soft tissue parameters has seldom been investigated. The aim of this study was to evaluate One with a cross-linked membrane used in secondary intention healing and the other with a non-cross-linked membrane used in primary intentional healing. Thirty subjects requiring tooth extraction were randomly allocated to either control group C (allograft covered with a non-cross-linked collagen membrane with primary closure) or experimental group E (allograft covered with cross-linked collagen membrane left exposed). Sites were surgically re-entered at 6-months. Soft and hard tissue measurements, cone beam computed tomography (CBCT) and cast measurements were taken at baseline & 6-months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Socket preservation control. After tooth extraction, bone graft is applied to socket and a non-cross-linked membrane is used in primary intentional healing. |
|
| Experimental | Experimental | Socket preservation experimental. After tooth extraction, bone graft is applied to socket and a cross-linked membrane is used in secondary intention healing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Socket preservation control | Procedure | After a tooth was extracted, the adjacent gum tissue was fully reflected, bone graft (FDBA) and non-cross-linked barrier membrane (Bio-Gide) were applied to the defect. The site was stabilized with sutures. Patients were followed for 6 months post operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Keratinized tissue width | Keratinized gingival tissue width measured from the free gingival margin to the muco-gingival junction. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Keratinized tissue thickness | Keratinized gingival tissue thickness measured with a needle and stopper 3mm from the free gingival margin. | 6 months |
| Vestibular Depth | The distance from the free gingival margin to the apical extent of the vestibule measured with a probe. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eli Machtei, DMD | Harvard School of Dental Med. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard School of Dental Medicine | Boston | Massachusetts | 02115 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 22, 2016 | Apr 5, 2018 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 6, 2016 | Apr 5, 2018 | Prot_SAP_001.pdf |
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Participants were assigned to one of two groups in parallel for the duration of the study.
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| Socket preservation experimental | Procedure | After a tooth was extracted, the adjacent gum tissue was minimally reflected, bone graft (FDBA) and cross-linked barrier membrane (OssixPlus) were applied to the defect. The site was stabilized with sutures. Patients were followed for 6 months post operatively. |
|
| 6 months |
| CEJ-FGM | The distance from the tooth's cervical enamel junction (CEJ) to the free gingival margin (FGM) was taken with a probe. | 6 months |
| Ridge Width | After the gum tissue is reflected, the width of the ridge 6mm from the crest was measured with a caliper. | 6 months |
| CEJ- Buccal crest | The distance from the tooth's cervical enamel junction and the top of the buccal bone crest was taken with a probe. | 6 months |
| CBCT bone height | CBCT scans were taken and the alveolar ridge height was then measured. | 6 months |
| CBCT bone width | CBCT scans were taken and the alveolar ridge width was then measured. | 6 months |
| Cast ridge width | Dental impressions were taken and stone casts obtained from them.The ridge width was then measured with calipers. | 6 months |
| Cast ridge volume | Dental impressions were taken and stone casts obtained from them.The ridge volume was measured using an optical scanner. | 6 months |