Clinical and Radiographic of the Effect of Socket Preservation Using the Roll Pedicle Connective Tissue Graft With Bovine Bone: A Case Series Trial.
Clinical and Radiographic Evaluation of the Effect of Socket Preservation Using the Roll Pedicle Connective Tissue Graft With Bovine Bone: A Case Series Trial.
1 other identifier
interventional
8
1 country
1
Brief Summary
After tooth extraction, the residual alveolar ridge generally provides limited bone volume because of ongoing, progressive bone resorption. Healing events within post-extraction sockets reduce the dimensions of the socket over time. Therefore, socket preservation became an indispensable procedure as well as fundamental to prevent bone loss following tooth extraction. Preservation, by the name, is the maintenance of the socket, which is essentially the height and width of the gap that is left after the tooth is removed. It is done by placing a graft material or scaffold immediately into the socket of an extracted tooth to presto preserve bone height, width and density
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2021
CompletedFirst Submitted
Initial submission to the registry
February 8, 2022
CompletedFirst Posted
Study publicly available on registry
February 24, 2022
CompletedMarch 11, 2022
February 1, 2022
1.6 years
February 8, 2022
February 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
width of alveolar bone
Two holes will be made in the acrylic stent (3mm and 5 mm below the alveolar crest) on the buccal and palatal extensions within the midline of the tooth to be extracted. The buccopalatal width of the alveolar ridge will be measured at the two assigned points using bone caliper at baseline and 6 months post extraction
changes in the Width of alveolar bone were measured at 3& 5 mm at baseline,3 months and 6 months
Secondary Outcomes (2)
gingival thickness
changes in the gingival thickness were measured at 3 & 5mm at (baseline,3 months and 6 months)
height of the alveolar crest
changes in height of alveolar crest were measured at baseline, 3 months and 6 months
Study Arms (1)
roll pedicle connective tissue graft with bovine bone
EXPERIMENTAL1. sulcular incisions were performed on the buccal and lingual aspects of the teeth to be extracted 2. Atraumatic extraction was made by periotome. 3. After tooth extraction the soft tissue was reflected at least 4 mm beyond the alveolar crest margin and the socket was filled with bovine derived xenograft and covered with roll pedicle connective tissue graft as a barrier membrane. 4. This pedicle is rolled under the buccal mucosa.The palatal connective tissue pedicle graft was outlined by full thickness incision along the oblique incision line, and parallel incision given from the mesial line angle of target place and reflected coronally up to the crest of the ridge defect. then a partial thickness incision was made extending beyond the line angles of adjacent incisors and mucogingival junction, leaving the periosteum on the bone. 5. the pedicle graft was rolled from the apical end and secured with interrupted sutures to the labial flap.
Interventions
rotated pedicle connective tissue graft together with bovine bone applied for socket preservation after tooth extraction
Eligibility Criteria
You may qualify if:
- patients with healthy systemic condition.
- Adult patients ˃ 18 years old.
- hopeless teeth that need tooth or root extraction in the maxillary esthetic zone.
- Alveolar socket Grade I and II.
- Normal platelet counts according to complete blood count (CBC) test done in the screening stage.
You may not qualify if:
- Acute infection at the extraction site
- Smokers ˃ 10 cigarettes / day.
- Medications that may interfere with wound healing
- History of treatment with bisphosphonates.
- History of allergic reaction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry -Cairo University
Giza, 0020, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
noha magdy salem amin
cairo university- faculty of dentistry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
February 8, 2022
First Posted
February 24, 2022
Study Start
July 16, 2019
Primary Completion
March 1, 2021
Study Completion
September 16, 2021
Last Updated
March 11, 2022
Record last verified: 2022-02