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.

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

Study Overview

• Status: Completed
• Conditions: Socket Preservation
• Intervention / Treatment: Procedure: roll pedicle connective tissue graft with bovine bone

Detailed Description

Investigator evaluate the clinical and radio graphic effect of roll pedicle connective tissue graft as a barrier membrane together with bovine bone in alveolar ridge preservation in extraction sockets.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 0020
    • Faculty of Dentistry -Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 27 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: roll pedicle connective tissue graft with bovine bone; sulcular incisions were performed on the buccal and lingual aspects of the teeth to be extracted; Atraumatic extraction was made by periotome.; 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.; 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.; the pedicle graft was rolled from the apical end and secured with interrupted sutures to the labial flap.

Procedure: roll pedicle connective tissue graft with bovine bone; rotated pedicle connective tissue graft together with bovine bone applied for socket preservation after tooth extraction; Other Names: vascularized interpositional connective tissue graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
gingival thickness	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 gingival thickness will be evaluated by William's graduated periodontal probe inserted horizontally perpendicular to the alveolar bone at the two assigned holes labially/buccally at baseline and 6 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 gingival thickness will be evaluated by William's graduated periodontal probe inserted horizontally perpendicular to the alveolar bone at the two assigned holes labially/buccally at baseline and 6 months post extraction. months post extraction.	changes in the gingival thickness were measured at 3 & 5mm at (baseline,3 months and 6 months)
height of the alveolar crest	Crestal bone height was measured to determine the amount of bone at gain using digora soft ware	changes in height of alveolar crest were measured at baseline, 3 months and 6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: noha magdy salem amin, Cairo University- Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): September 16, 2021

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: socket preservation; vascularized interpositional connective tissue graft; alveolar ridge preservation techniques; bovine bone graft; roll pedicle graft
• Other Study ID Numbers: roll pedicle graft

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No