Investigate New Surgical Techniques to Improve Esthetics and Patient Satisfaction at Implant Sites
Primary Purpose
Fractured Tooth
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
socket shield technique with xenophobic graft particulate and without the use of graft
Sponsored by
About this trial
This is an interventional treatment trial for Fractured Tooth
Eligibility Criteria
Inclusion Criteria:
- Patients with non-restorable maxillary anterior teeth in the esthetic zone indicated for implant placement.
- Both sexes.
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement
Exclusion Criteria:
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Uncontrolled diabetic patients.
- Pregnant patients.
- Teeth with Large pulpal pathosis as cysts, large periapical granulomas
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
- Immunodeficiency pathology, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
- Psychiatric problems.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
grafted versus graft less socket shield technique
Arm Description
Outcomes
Primary Outcome Measures
Marginal bone loss
Will be measured using linear measurements from CBCT
Secondary Outcome Measures
secondary stability
Will be measured using Osstell
Full Information
NCT ID
NCT04101552
First Posted
September 22, 2019
Last Updated
September 23, 2019
Sponsor
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT04101552
Brief Title
Investigate New Surgical Techniques to Improve Esthetics and Patient Satisfaction at Implant Sites
Official Title
Clinical and Radiographic Assessment of Immediate Implant Placement in Maxillary Esthetic Zone Using Socket Shield Technique With and Without the Use of Xenograft Particulate Graft Material
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2019 (Anticipated)
Primary Completion Date
February 20, 2020 (Anticipated)
Study Completion Date
August 20, 2020 (Anticipated)
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
Yes
5. Study Description
Brief Summary
Many techniques have been proposed to prevent or rather minimize the labial bone resorption following extraction including guided bone regeneration techniques that has been attempted for many years now to preserve the alveolar ridge dimensions .
Immediate implant placement, flapless implant placement, palataly positioned implants and even platform switching.
However none of these methods were able to completely preserve the coronal part of the facial bone wall, and since the main reason of bone loss following extraction is the loss of the periodontal ligament, it seemed logical that root retention may affect the resorption process,The reason the root retention technique works in its different applications is due to the maintenance of the periodontal attachment including cementum, periodontal ligaments and bundle bone, this principle was used by Hurzeler in 2010 in a technique called socket shied technique.
Detailed Description
The selected patients will be informed of the nature of the research work and informed consent will be obtained then randomized in equal proportions between control group conventional immediate implant placement with immediate temporization and study group socket shield technique with immediate temporization.
Patients of both groups will be subjected to CBCT (diagnostic for upper arch).
Intra operative procedures (for both groups) followed by CBCT will be taken for every patient
Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine)
Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
In the study group: along surgical fissure bur will be used for hemisectioning.
The palatal portion will be carefully separated and extracted by a periotome and forceps.
The osteomy site will be inspected and cleaned from any granulation tissue and the implant will be placed palatal to the tooth fragment.
The jump gap was grafted with a xenogeneic bone particulate (De-proteinized bovine bone mineral Small granules (0.25-1 mm), the implant gained primary stability from bone apical and palatal sufficient to immediately restore with provisional restoration.
In the control group: the root was hemisected using a fissure bur in a mesio-distal direction, and a traumatic removal of the palatal fragment of the root was achieved (no pressure was applied on it), then the buccal fragment was reduced using surgical bur leaving a thin layer of the root aspect intact to the buccal plate of the bone.
The implant is placed in the socket in a way leaving space away from the remaining buccal plate without grafting this jumping gap
The provisional restorations were relieved of occlusal contacts in centric occlusion and excursive movements. These restorations remained in situ for at least 6 to 12 weeks prior to any modifications or commencement of definitive restorative therapy
A soft diet was recommended for the duration of the implant-healing phase. The patient was advised against functioning or activities to the implant site.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractured Tooth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
grafted versus graft less socket shield technique
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
socket shield technique with xenophobic graft particulate and without the use of graft
Intervention Description
the jumping gap between the implant and the shield is grafted by xenograft particulate and the control group is not grafted
Primary Outcome Measure Information:
Title
Marginal bone loss
Description
Will be measured using linear measurements from CBCT
Time Frame
• Amount of bone loss will be measured after 6 month using linear measurement from CBCT
Secondary Outcome Measure Information:
Title
secondary stability
Description
Will be measured using Osstell
Time Frame
will be measured intraoperative and 3 months after surgery
Other Pre-specified Outcome Measures:
Title
pink esthetic score
Description
Will be measured using pink esthetic index chart
Time Frame
Pink esthetics will be measured using pink esthetic index chart After 6 months.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with non-restorable maxillary anterior teeth in the esthetic zone indicated for implant placement.
Both sexes.
No intraoral soft and hard tissue pathology
No systemic condition that contraindicate implant placement
Exclusion Criteria:
Heavy smokers more than 20 cigarettes per day.
Patients with systemic disease that may affect normal healing.
Uncontrolled diabetic patients.
Pregnant patients.
Teeth with Large pulpal pathosis as cysts, large periapical granulomas
Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
Immunodeficiency pathology, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Psychiatric problems.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Poosy H. Mohamed, principal investigator
Phone
01098008064
Ext
00202
Email
pussy_hany@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed A. Abdelrasoul, lecturer
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Investigate New Surgical Techniques to Improve Esthetics and Patient Satisfaction at Implant Sites
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