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Completed

NCT Number: NCT05381467

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

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.

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Key information

Conditions

Immediate Implants Alveolar Bone Loss Bone Diseases Bone Resorption Dual Zone Technique Esthetic Zone Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases the Bone Shielding Concept

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ElAskary dental center

Alexandria, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. Pink Esthetic Score

    Time frame: 6 months

    Pink Esthetic Score 1-14 score PES

Secondary outcomes

  1. labial bone thickness

    Time frame: 6 months

    radiographic CBCT

  2. Peri-implant probing depth

    Time frame: 6 months

    mm

  3. Implant failure

    Time frame: 6 months

    yes/No

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 19, 2022
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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