Evaluation of Immediate Implant Placement In The Esthetic Zone Using Vestibular Socket Therapy Versus Dual Zone Therapy

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05381467

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Immediate implant placement has proven to be a successful treatment procedure that is preferred by patients because of being less traumatic, more time-efficient. Nowadays, the main goal of a successful immediate implant treatment has ceased to be gaining stability and osseointegration, but achieving long-term dimensional stability has become the optimal challenge. Various soft tissue and hard tissue augmentation techniques have been investigated in order to maintain the ridge dimensions following extraction and immediate implant placement.

Condition or Disease	Intervention/Treatment	Phase
Immediate Implants VST Dual Zone Technique Vestibular Socket Therapy	Procedure: immediate implant placement with The Dual-Zone Therapeutic Concept Procedure: Immediate implant placement with vestibular socket therapy	N/A

Detailed Description

It has been noted that the different augmentation procedures aid in decreasing the dimensional changes occurring after immediate implant placement in the esthetic zone. Even though immediate implant placement is a predictable procedure, however, labial bone resorption following tooth extraction is inevitable. The available surgical techniques present do not entirely prevent dimensional variations of the peri-implant hard and soft tissues over time. Furthermore, substantial evidence showed that immediate implant placement failed to halt the resorption of the thin buccal bony plate with subsequent gingival recession, particularly in patients with thin gingival phenotype

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Clinical And Radiographic Evaluation of Immediate Implant Placement In The Esthetic Zone Using Vestibular Socket Therapy Versus Dual Zone Therapy: A Randomized Clinical Trial

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: immediate implant placement with The Dual-Zone Therapeutic Concept	Procedure: immediate implant placement with The Dual-Zone Therapeutic Concept After tooth removal, implant placement, bone grafting, and screw retained provisional restoration, the contour of the ridge can change. Using dual zone grafting was claimed to minimize contour change associated with immediate anterior implants. In this technique. The implant should be placed in an optimal 3 dimensional mode . Xenograft, will be used in the gap to graft the bone and tissue zones, . The graft material helps serve as a scaffold to maintain hard- and soft-tissue volume as well as blood clot for initial healing.
Experimental: Immediate implant placement with vestibular socket therapy	Procedure: Immediate implant placement with vestibular socket therapy After atraumatic tooth extraction using periotomes and luxators , socket curettage and cleaning simultaneously using the VST irrigation curette will be performed. A 1 cm long vestibular access incision will be made using a 15c blade at the most apical part of the socket sulcus to expose the socket bone, followed with periosteal dissection in an incisal direction towards the socket orifice, using VST vestibular elevator. Then, dissection of the remaining attached tissue close to the socket orifice incisally and apically will be done using the VST hammerhead periotome to create a tunnel between the socket orifice and the vestibular access incision. implant will be placed.The vestibular tissues will be retracted using the VST forklift retractor to allow a complete access of the labial plate of bone where all the regenerative materials will be delivered. A membrane will be inserted to the labial tunnel using the VST bone shield holder, and tacked using 2 membrane tacks

Arm

Intervention/Treatment

Active Comparator: immediate implant placement with The Dual-Zone Therapeutic Concept

Procedure: immediate implant placement with The Dual-Zone Therapeutic Concept

After tooth removal, implant placement, bone grafting, and screw retained provisional restoration, the contour of the ridge can change. Using dual zone grafting was claimed to minimize contour change associated with immediate anterior implants. In this technique. The implant should be placed in an optimal 3 dimensional mode . Xenograft, will be used in the gap to graft the bone and tissue zones, . The graft material helps serve as a scaffold to maintain hard- and soft-tissue volume as well as blood clot for initial healing.

Experimental: Immediate implant placement with vestibular socket therapy

Procedure: Immediate implant placement with vestibular socket therapy

After atraumatic tooth extraction using periotomes and luxators , socket curettage and cleaning simultaneously using the VST irrigation curette will be performed. A 1 cm long vestibular access incision will be made using a 15c blade at the most apical part of the socket sulcus to expose the socket bone, followed with periosteal dissection in an incisal direction towards the socket orifice, using VST vestibular elevator. Then, dissection of the remaining attached tissue close to the socket orifice incisally and apically will be done using the VST hammerhead periotome to create a tunnel between the socket orifice and the vestibular access incision. implant will be placed.The vestibular tissues will be retracted using the VST forklift retractor to allow a complete access of the labial plate of bone where all the regenerative materials will be delivered. A membrane will be inserted to the labial tunnel using the VST bone shield holder, and tacked using 2 membrane tacks

Outcome Measures

Primary Outcome Measures

Pink Esthetic Score [6 months]
Pink Esthetic Score

Secondary Outcome Measures

labial bone thickness [6 months]
radiographic CBCT
Peri-implant probing depth [6 months]
mm
Implant failure [6 months]
yes/No

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

adult (>18 years) patients having a single non-adjacent hopeless maxillary tooth in the esthetic zone
type I socket (intact but thin labial plate of bone and intact overlying soft tissues)
adequate palatal bone
≥3 mm apical bone to engage the immediately placed implants
optimum primary stability (a minimum of 30 Ncm insertion torque) following tooth extraction.

Exclusion Criteria:

smokers
pregnant women
patients with systemic diseases
periodontal disease, gingival recession
infected sockets
periapical pathosis and history of chemotherapy or radiotherapy within the past 2 years.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Abdelsalam El Askary, private practice, Alexandria, Egypt
Study Chair: Noha A Ghallab, PhD, Professor in the department of oral Medicine & Periodontology, Cairo University
Study Director: Nesma M shemais, PhD, Lecturer in the department of oral Medicine & Periodontology, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nesma Mohamed Fouad Shemais, PhD holder Lecturer in the department of Oral Medicine & Periodontology, Cairo University

ClinicalTrials.gov Identifier:

NCT05381467

Other Study ID Numbers:

AAN.1

First Posted:

May 19, 2022

Last Update Posted:

May 19, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

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

Keywords provided by Nesma Mohamed Fouad Shemais, PhD holder Lecturer in the department of Oral Medicine & Periodontology, Cairo University

esthetic zone

soft tissue augmentation

Study Results

No Results Posted as of May 19, 2022