Evaluation of Immediate Implant Placement In The Esthetic Zone Using the Bone Shielding Concept Versus Dual Zone Therapy

The Bone Shielding Versus Dual Zone Concept in Treating Thin Walled Fresh Extraction Sockets With Immediate Implant Placement Soft and Hard Tissue Changes A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Loss; Immediate Implants; Esthetic Zone; Dual Zone Technique; the Bone Shielding Concept
• Intervention / Treatment: Procedure: immediate implant placement with The Dual-Zone Therapeutic Concept; Procedure: Immediate implant placement with the bone shielding concept

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • ElAskary dental center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 the bone shielding concept	Procedure: Immediate implant placement with the bone shielding concept; After atraumatic tooth extraction using periotomes and luxators , socket curettage and cleaning simultaneously using an irrigation curette will be performed. Sulcular dissection of the attached tissue close to the socket orifice incisal and apically will be done using periotome to create a tunnel via the socket orifice. Dental implant will be placed. complete access of the labial plate of bone where all the regenerative materials will be performed to have the bone sheild delivered. A membrane will be inserted to the labial tunnel and tacked using 2 membrane tacks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pink Esthetic Score	Pink Esthetic Score 1-14 score PES	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
labial bone thickness	radiographic CBCT	6 months
Peri-implant probing depth	mm	6 months
Implant failure	yes/No	6 months

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 14, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: soft tissue augmentation; esthetic zone
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: AAN.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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