Vestibular Socket Therapy With and Without Bone Grafting

• Sponsor: Hams Hamed Abdelrahman (Other)
• Overall Status: Completed
• CT.gov ID: NCT04930497
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.4
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Tooth Extraction	Procedure: vestibular socket technique with bone grafting; Procedure: vestibular socket technique without bone grafting	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Immediate Implant Placement Using Vestibular Socket Therapy With and Without Bone Grafting (Randomized Controlled Clinical Trial)
• Actual Study Start Date: Nov 20, 2019
• Actual Primary Completion Date: Jan 30, 2021
• Actual Study Completion Date: Jan 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Facial bone thickness [baseline, 6 months and 13 months]

   using CBCT scans (Carestream 8000D, Carestream Dental)

2. Change in Facial bone height [baseline, 6 months and 13 months]

   using CBCT scans (Carestream 8000D, Carestream Dental)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Private Practice Clinic	Alexandria		Egypt

Sponsors and Collaborators

• Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University
• ClinicalTrials.gov Identifier: NCT04930497
• Other Study ID Numbers: VST_bone grafting
• First Posted: Jun 18, 2021
• Last Update Posted: Jul 23, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 23, 2021