- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06881095
Immediate Dental Implant Installation with and Without Socket Shield Technique in Aesthetic Zone (socket shield)
20 patients with non-restorable anterior teeth underwent extraction with immediate implant installation using either the immediate implant with socket shield technique or the conventional immediate dental implant.
the socket shield technique group (study group): 10 patients will have immediate implant placement with the socket shield technique.
- conventional immediate dental implant technique (control group): 10 patients will have immediate implant placement with conventional technique.
Study Overview
Status
Conditions
Detailed Description
20 patients with non-restorable anterior teeth underwent extraction with immediate implant installation randomized to two groups immediate dental implant with the socket shield technique group (study group): 10 patients will have immediate implant placement with socket shield technique.
- conventional immediate dental implant technique (control group): 10 patients will have immediate implant placement with conventional technique without socket shield technique.
preparation of shield: the root will be sectioned in a mesio-distal direction along its long axis, sectioning divided the tooth root into one facial third and two palatal thirds, Periotomes will then be inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root was then carefully delivered so as not to disturb the facial root section, the remaining root section was then reduced coronally to 1 mm above the alveolar crest.
The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section was checked for immobility with a sharp probe.
After completion of the previous steps, the tooth root here will be known as the socket- shield (SS). An osteotomy was then sequentially prepared according to manufacturer instructions and a suitable implant then inserted palatal to the SS.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tanta, Egypt, 3111
- Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1. Non restorable maxillary anterior teeth without periapical pathology that may affect the success of dental implants.
2. Interarch space enough for prosthetic rehabilitation. 3. Presence of posterior teeth or prosthesis that maintain occlusal bite. 4. Adult patients. 5. Good oral hygiene.
Exclusion Criteria:
- 1. Edentulous anterior maxillary region. 2. Bad oral hygiene. 3. Patients with any relevant systemic diseases that affect soft tissue or bone healing.
4. Patients with parafunctional habits (bruxism and clenching). 5. Uncooperative patients. 6. Heavy smokers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: socket shield technique group (study group)
the socket shield technique group (study group): 10 patients will have immediate implant placement with socket shield technique.
preparation of shield: the root will be sectioned in a mesio-distal direction along its long axis, sectioning divided the tooth root into one facial third and two palatal thirds, Periotomes will then be inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root was then carefully delivered so as not to disturb the facial root section, the remaining root section was then reduced coronally to 1 mm above the alveolar crest. The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section was checked for immobility with a sharp probe. After completion of th |
immediate implant installation with socket shield technique: After administration of local anesthesia, the root will be sectioned in a mesio-distal direction along its long axis, sectioning divided the tooth root into one facial third and two palatal thirds. Periotomes will then be inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root was then carefully delivered so as not to disturb the facial root section, the remaining root section was then reduced coronally to 1 mm above the alveolar crest. The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants, and the root section was checked for immobility with a sharp probe. After completion of the previous steps, the tooth root here will be known as the socket- shield (SS). An osteotomy was then sequentially prepared according to manufacturer
Other Names:
|
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Experimental: conventional immediate implant without socket shield technique(control group)
conventional immediate implant without socket shield technique: • After administration of local anesthesia, atraumatic tooth extraction by extraction forceps and Periotomes, an osteotomy was then sequentially prepared according to manufacturer instructions and a suitable implant then inserted and placement of cover screw. However, the soft tissue contour formed after healing may need some modification prior to impression taking. Suturing around the healing abutment, suture will be removed one week post surgically and then healing abutment and final prosthetic loading will be done after 4-6 months. |
• After administration of local anesthesia, atraumatic tooth extraction by extraction forceps and Periotomes, an osteotomy was then sequentially prepared according to manufacturer instructions and a suitable implant then inserted and placement of cover screw.
However, the soft tissue contour formed after healing may need some modification prior to impression taking.
Suturing around the healing abutment, suture will be removed one week post surgically and then healing abutment and final prosthetic loading will be done after 4-6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
marginal bone loss
Time Frame: 6 months
|
6 months
|
|
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labial bone thickness
Time Frame: 6 months
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1. labial bone thickness measuring thickness of labial bone labial to the implant by (CBCT) Cone beam computed tomography
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
bone density around dental implant
Time Frame: 6 months
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bone density around dental implant by Cone beam computed tomography
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6 months
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implant secondary stability
Time Frame: 6 months
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Secondary implant stability: will be recorded just after uncovery using Resonance frequency analysis (RFA) device * (Osstell).
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6 months
|
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implant success
Time Frame: 6 months
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absence of infection, fistula formation or implant mobility
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6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rafic ramadan bedir, professor, faculty of dentistry Tanta university
- Principal Investigator: Ibrahim mohammed nowair, professor, faculty of dentistry Tanta university
- Principal Investigator: islam ahmed abo elela, master study, faculty of dentistry Tanta university
- Principal Investigator: Wesam Hamed Elsaadany, lecturer, faculty of dentistry Tanta university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- islam123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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