Vestibular Socket Therapy With Simultaneous Implant Placement Versus Contour Augmentation With Early Implant Placement

Vestibular Socket Therapy With Simultaneous Implant Placement Versus Contour Augmentation With Early Implant Placement in Fresh Extraction Sockets : A Randomized Clinical Trial

immediate implant placement with VST technique versus early implant placement with contour augmentation in fresh extraction sockets in the esthetic zone.

Study Overview

• Status: Not yet recruiting
• Conditions: Loss of Teeth Due to Extraction
• Intervention / Treatment: Procedure: immediate implant

Detailed Description

comparing VST technique with immediate implant placement that end up with final crown after 2 months with contour augmentation with early implant placement after 4- 8 weeks of soft tissue healing , then after 3 months final crown delivery both in fresh extraction sockets in the esthetic zone .

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: amir elawady, BDS; Phone Number: 00201020205791; Email: amir112093@miuegypt.edu.eg
• Study Contact Backup: Name: Mohamed Elkhashab, PHD; Phone Number: 00201006611525; Email: mohamed.elkhashab@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11518
    • Iman AbdelWahab Radi
  • Giza
    • Cairo, Giza, Egypt, 11865
      • Faculty of Dentistry Cairo University
      • Contact: amir alaa elawady, BDS; Phone Number: 00201020205791; Email: amir112093@miuegypt.edu.eg
      • Contact: Mohamed Amr Elkhashab, PHD; Phone Number: 01006611525; Email: mohamed.elkhashab@dentistry.cu.edu.eg
  • Manial
    • Cairo, Manial, Egypt, 12911
      • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Non-restorable maxillary teeth in the esthetic zone

Intact adjacent teeth

Adequate palatal and apical bone that allows achieving implant primary stability.

Compromised sockets type II defect (Nicolas Elian 2007)

≥18 years

Systemically healthy patients

Exclusion Criteria:

Extraction sockets with acute or chronic infection or with adjacent infected teeth

Heavy Smokers > than 10 cigarettes daily

Cancer patients undergoing radiotherapy or chemotherapy during or within the last 6 months.

Unmotivated patients to maintain adequate oral hygiene to follow up.

Patients with physical disabilities that could affect follow up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vestibuler socket therapy; immediate implant placement in esthatic zone with final crown placement after 2 months with VST technique	Procedure: immediate implant; immediate implant placement with VST technique versus early implant placement with contour augmentation technique
Experimental: contour augmentation; Early implant placement in esthatic zone with contour augmentation and final crown after 3 months of implant placement	Procedure: immediate implant; immediate implant placement with VST technique versus early implant placement with contour augmentation technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival	If there is no pain or tenderness on use, no mobility, no history of exudates and radiographic bone loss is less than 2 mm from initial surgery implant the implant is considered successful	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the height and thickness of the labial plate of bone	will be measured by superimposing CBCT images obtained at the baseline (time of tooth extraction) and those after 12 months postimplant placement.	12 months
Changes in soft tissue height	were identified midfacially and at the apex of the mesial and distal papillae by superimposing the STL (Standard Triangle Language) files of the models, obtained via IOS, at the baseline (of the unrestorable tooth) with those after 12 months of implant insertion	12 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Iman Radi, PHD, Professor of prosthodontics; Study Director: AbdelSalam ElAsakry, BDS, Private Practice

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: vst versus contour aug.

Drug and device information, study documents

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