Vestibular Socket Therapy With and Without Bone Grafting

Immediate Implant Placement Using Vestibular Socket Therapy With and Without Bone Grafting (Randomized Controlled Clinical Trial)

Management of the jumping gap in the Vestibular Socket Therapy. And to study what is the best technique to manage this gap for optimal esthetic result.

Study Overview

• Status: Completed
• Conditions: Tooth Extraction
• Intervention / Treatment: Procedure: vestibular socket technique with bone grafting; Procedure: vestibular socket technique without bone grafting

Detailed Description

22 patients were randomly assigned to Group 1: Had received implants with the vestibular socket technique accompanied with bone grafting the jumping gap between the implant and the labial membrane.

Group 2: Had received implants with the vestibular socket technique, but without bone grafting the jumping gap.

Facial bone thickness and height were evaluated using CBCT scans at baseline before tooth extraction and after 6 and 13 months

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Private Practice Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• presence of a hopeless tooth or teeth in the esthetic zone (maxillary anterior area)
• No active infection
• Adequate bone palatally and apically
• Presence of contralateral tooth for the tooth being replaced

Exclusion Criteria:

• Hopeless tooth with acute infection
• heavy smokers (more than 10 cigarettes per day)
• pregnant and patients received recent chemotherapy/radiotherapy (during the previous year)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vestibular socket technique with bone grafting	Procedure: vestibular socket technique with bone grafting; a vestibular horizontal incision was made then a subperiosteal tunnel was created and a facial bone membrane was placed. The facial gap was filled with a mixture of autogenous bone and deproteinized bovine bone mineral
Active Comparator: vestibular socket technique without bone grafting	Procedure: vestibular socket technique without bone grafting; the vestibular incision was done horizontally about 3 to 4 mm apical to the mucogingival junction and extending 5 to 10 mm horizontally. A submucoperiosteal tunnel was created labially from the socket orifice till the vestibular access incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Facial bone thickness	using CBCT scans (Carestream 8000D, Carestream Dental)	baseline, 6 months and 13 months
Change in Facial bone height	using CBCT scans (Carestream 8000D, Carestream Dental)	baseline, 6 months and 13 months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 17, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: VST_bone grafting

Drug and device information, study documents

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