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

NCT ID: NCT05381467

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-12-15

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.

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

immediate implant placement with The Dual-Zone Therapeutic Concept

Group Type: ACTIVE_COMPARATOR

immediate implant placement with The Dual-Zone Therapeutic Concept

Intervention Type: 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 bone shielding concept

Group Type: EXPERIMENTAL

Immediate implant placement with the bone shielding concept

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nesma Mohamed Fouad Shemais

PhD holder Lecturer in the department of Oral Medicine & Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdelsalam El Askary

Role: PRINCIPAL_INVESTIGATOR

private practice, Alexandria, Egypt

Noha A Ghallab, PhD

Role: STUDY_CHAIR

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

Nesma M shemais, PhD

Role: STUDY_DIRECTOR

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

Locations

ElAskary dental center

Alexandria, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 37669913 (View on PubMed)

Other Identifiers

AAN.1

Identifier Type: -

Identifier Source: org_study_id