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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05005585

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

9.3

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Loss of Teeth Due to Extraction	Procedure: immediate implant	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Outcomes Assessor)

Masking Description:

outcome assessor isnt involved in the intervension

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Implant survival [12 months]
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

Secondary Outcome Measures

Changes in the height and thickness of the labial plate of bone [12 months]
will be measured by superimposing CBCT images obtained at the baseline (time of tooth extraction) and those after 12 months postimplant placement.
Changes in soft tissue height [12 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of dentistry Cairo university	Cairo	Giza	Egypt	11865
2	Faculty of dentistry	Cairo	Manial	Egypt	12911
3	Iman AbdelWahab Radi	Cairo		Egypt	11518

Sponsors and Collaborators

Cairo University

Investigators

Study Director: Iman Radi, PHD, Professor of prosthodontics
Study Director: AbdelSalam ElAsakry, BDS, Private Practice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Iman Abd-ElWahab Radi, PhD, Professor of Prosthodontics, Faculty of Dentistry, Cairo University, Cairo University

ClinicalTrials.gov Identifier:

NCT05005585

Other Study ID Numbers:

vst versus contour aug.

First Posted:

Aug 13, 2021

Last Update Posted:

Nov 18, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tooth Loss

Study Results

No Results Posted as of Nov 18, 2021