An interventional study of Socket preservation control and Socket preservation experimental in Ridge Preservation and Bone Regeneration, sponsored by Harvard School of Dental Medicine. Completed at 1 site in United States. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-13.
Sponsored by Harvard School of Dental Medicine · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Socket preservation control. After tooth extraction, bone graft is applied to socket and a non-cross-linked membrane is used in primary intentional healing.
Procedure: Socket preservation control
Socket preservation experimental. After tooth extraction, bone graft is applied to socket and a cross-linked membrane is used in secondary intention healing.
Procedure: Socket preservation experimental
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.
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.
Keratinized tissue width
Keratinized gingival tissue width measured from the free gingival margin to the muco-gingival junction.
Time frame: 6 months
Keratinized tissue thickness
Keratinized gingival tissue thickness measured with a needle and stopper 3mm from the free gingival margin.
Time frame: 6 months
Vestibular Depth
The distance from the free gingival margin to the apical extent of the vestibule measured with a probe.
Time frame: 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.
Time frame: 6 months
Ridge Width
After the gum tissue is reflected, the width of the ridge 6mm from the crest was measured with a caliper.
Time frame: 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.
Time frame: 6 months
CBCT bone height
CBCT scans were taken and the alveolar ridge height was then measured.
Time frame: 6 months
CBCT bone width
CBCT scans were taken and the alveolar ridge width was then measured.
Time frame: 6 months
Cast ridge width
Dental impressions were taken and stone casts obtained from them.The ridge width was then measured with calipers.
Time frame: 6 months
Cast ridge volume
Dental impressions were taken and stone casts obtained from them.The ridge volume was measured using an optical scanner.
Time frame: 6 months
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Plan to share: No
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Harvard School of Dental Medicine