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

NCT05381467 | Completed

• 1 other identifier: AAN.1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Immediate Implants; Alveolar Bone Loss; Dual Zone Technique; the Bone Shielding Concept; Esthetic Zone

Keywords

esthetic zone; soft tissue augmentation

Outcome Measures

Primary Outcomes (1)

• Pink Esthetic Score

  Pink Esthetic Score 1-14 score PES

  6 months

Secondary Outcomes (3)

• labial bone thickness

  6 months

• Peri-implant probing depth

  6 months

• Implant failure

  6 months

Study Arms (2)

immediate implant placement with The Dual-Zone Therapeutic Concept

ACTIVE COMPARATOR

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

Immediate implant placement with the bone shielding concept

EXPERIMENTAL

Procedure: Immediate implant placement with the bone shielding concept

Interventions

immediate implant placement with The Dual-Zone Therapeutic Concept PROCEDURE

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.

immediate implant placement with The Dual-Zone Therapeutic Concept

Immediate implant placement with the bone shielding concept PROCEDURE

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.

Immediate implant placement with the bone shielding concept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

ElAskary dental center

Alexandria, Egypt

Location

Related Publications (1)

• Elaskary A, Ghallab N, Thabet A, Shemais N. 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. Clin Implant Dent Relat Res. 2024 Feb;26(1):66-77. doi: 10.1111/cid.13275. Epub 2023 Sep 5.

  PMID: 37669913 DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Abdelsalam El Askary

  private practice, Alexandria, Egypt

  PRINCIPAL INVESTIGATOR

• Noha A Ghallab, PhD

  Professor in the department of oral Medicine & Periodontology, Cairo University

  STUDY CHAIR

• Nesma M shemais, PhD

  Lecturer in the department of oral Medicine & Periodontology, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD holder Lecturer in the department of Oral Medicine & Periodontology

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 19, 2022
• Study Start: March 1, 2022
• Primary Completion: November 15, 2022
• Study Completion: December 15, 2022
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)