Back to resultsEvaluation of Immediate Implant Placement In The Esthetic Zone Using the Bone Shielding Concept Versus Dual Zone Therapy
Primary Purpose
Immediate Implants, Alveolar Bone Loss, Dual Zone Technique
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
immediate implant placement with The Dual-Zone Therapeutic Concept
Immediate implant placement with the bone shielding concept
Sponsored by
About this trial
This is an interventional treatment trial for Immediate Implants focused on measuring esthetic zone, soft tissue augmentation
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.
Sites / Locations
- ElAskary dental center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
immediate implant placement with The Dual-Zone Therapeutic Concept
Immediate implant placement with the bone shielding concept
Arm Description
Outcomes
Primary Outcome Measures
Pink Esthetic Score
Pink Esthetic Score 1-14 score PES
Secondary Outcome Measures
labial bone thickness
radiographic CBCT
Peri-implant probing depth
mm
Implant failure
yes/No
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05381467
Brief Title
Evaluation of Immediate Implant Placement In The Esthetic Zone Using the Bone Shielding Concept Versus Dual Zone Therapy
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immediate Implants, Alveolar Bone Loss, Dual Zone Technique, the Bone Shielding Concept, Esthetic Zone
Keywords
esthetic zone, soft tissue augmentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
immediate implant placement with The Dual-Zone Therapeutic Concept
Arm Type
Active Comparator
Arm Title
Immediate implant placement with the bone shielding concept
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
immediate implant placement with The Dual-Zone Therapeutic Concept
Intervention Description
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
Intervention Name(s)
Immediate implant placement with the bone shielding concept
Intervention Description
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 Outcome Measure Information:
Title
Pink Esthetic Score
Description
Pink Esthetic Score 1-14 score PES
Time Frame
6 months
Secondary Outcome Measure Information:
Title
labial bone thickness
Description
radiographic CBCT
Time Frame
6 months
Title
Peri-implant probing depth
Description
mm
Time Frame
6 months
Title
Implant failure
Description
yes/No
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelsalam El Askary
Organizational Affiliation
private practice, Alexandria, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Noha A Ghallab, PhD
Organizational Affiliation
Professor in the department of oral Medicine & Periodontology, Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nesma M shemais, PhD
Organizational Affiliation
Lecturer in the department of oral Medicine & Periodontology, Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
ElAskary dental center
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of Immediate Implant Placement In The Esthetic Zone Using the Bone Shielding Concept Versus Dual Zone Therapy
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