- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05946954
Immediate Implant Placement Using Immediate Dentoalveolar Restoration Versus Ice Cream Cone Technique With Labial Plate Dehiscence
Evaluation of Soft and Hard Tissue Changes Following Immediate Implant Using Immediate Dentoalveolar Restoration Versus Ice Cream Cone Technique In Cases With Labial Plate Dehiscence: A 1-Year Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Non-restorable teeth in the esthetic zone with a defect of labial bone.
- Teeth with no acute inflammation.
- Patients are free from any systemic condition that may affect the healing.
- Availability of bone apical and palatal to the socket to provide primary stability
- Good oral health.
- Willingness to sign the informed consent form.
Exclusion Criteria:
Heavy smoker (> 10 cigarettes/day)
- Pregnant females
- Contraindication for Implant surgery.
- Patients with poor oral hygiene.
- Acute inflammation in the site of implantation and adjacent tissue.
- A history of radiotherapy in the head or neck region.
- Patients with systemic diseases like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group Immediate Dentoalveolar Restoration
|
Topical anesthesia will be administered using an infiltration technique. • Atraumatic extraction will be done with the aid of periotome and Luxators. • The extraction socket will be debrided to remove any residual debris or granulation tissue. •. Socket walls will be checked using a periodontal probe to ensure integrity of all sockets walls except the labial bone plate which must show a dehiscence. • Implant placement will be done according to manufactures' instructions; drills will be used sequentially in a more palatal direction leaving a buccal jumping gap of at least 2mm. All implants will engage at least 3 mm apical to the apical end of the socket with adequate primary stability |
Active Comparator: Control group Ice cream cone technique
Ice cream cone technique
The membrane will be folded in palatal direction to seal the socket in an ice cream cone shape, then will be secured using resorbable sutures to prevent dislodgment of the blood clot and bone grafting material |
Topical anesthesia will be administered using an infiltration technique. • Atraumatic extraction will be done with the aid of periotome and Luxators. • The extraction socket will be debrided to remove any residual debris or granulation tissue. •. Socket walls will be checked using a periodontal probe to ensure integrity of all sockets walls except the labial bone plate which must show a dehiscence. • Implant placement will be done according to manufactures' instructions; drills will be used sequentially in a more palatal direction leaving a buccal jumping gap of at least 2mm. All implants will engage at least 3 mm apical to the apical end of the socket with adequate primary stability |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bucco/facial-palatal ridge thickness
Time Frame: 1 year
|
Impressions were taken with addition silicone before tooth extraction, after six months of implant placement (immediately after the placement of the definite crown) and 12 months after crown installation.
Casts were then obtained with special gypsum stone type IV.Casts were measured by a dentist not involved in the study with a digital caliper.
Three reference points were measured from the free gingival margin to the apex at the implant site and in the contralateral tooth: 1 mm, 3 mm and 6 mm
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiographic vertical bone changes
Time Frame: 1 year
|
Vertical bone height will be measured.
Measurement will be taken at highest point of the remaining labial/buccal plate of bone using the implant neck as a reference point.
Each measurement will be recorded at different times and the difference between pre and post-operative measurements will be determined as the gain in labial/buccal vertical bone dimension
|
1 year
|
Gingival Thickness
Time Frame: 1 year
|
Gingival thickness will be evaluated 2 mm below the gingival margin with a short needle for and silicon disk stop.
The needle will be inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface was reached.
The silicone disc stop was then mounted in close contact with the gingival tissue surface.
The insertion depth was assessed with a digital caliper accurate to the nearest 0.1 mm
|
1 year
|
Width of the Keratinized Tissue
Time Frame: 1 year
|
It will be evaluated from the gingival margin to the mucogingival junction (MGJ).
The MGJ was assessed with roll technique
|
1 year
|
Midfacial recession
Time Frame: 1 year
|
Corono-apical distance between the peri-implant soft tissue margin and the cemento-enamel junction (CEJ) of the homologous contralateral tooth
|
1 year
|
Post-Operative Pain
Time Frame: 7 days
|
Pain will be assessed post-surgically using the Visual Analogue Scale (VAS) with numbers from 0 to 10 score zero represented no pain while score 10 represented the worst pain imaginable
|
7 days
|
Post-operative swelling
Time Frame: 7 days
|
Swelling will be assessed post-surgically using the Verbal Rating Scale (VRS) (García et al. 2008):
|
7 days
|
Radiographic bucco-palatal bone changes
Time Frame: 1 year
|
The bucco-palatal width of the alveolar bone will be measured perpendicular to the long axis of the alveolar bone; the 3 measurements will be the coronal width (CW), middle width (MW), and apical width (AW).
Each measurement will be recorded at different times
|
1 year
|
3. Radiographic width of bone labial to the implant
Time Frame: 1 year
|
Amount of bone labial to the implant will be measured perpendicular to the vertical line of the implant surface at the implant neck level or the top of the buccal bone (which is regarded as 0 mm), 3 mm and 6 mm apical to the implant neck Each measurement will be recorded at different times (at day 0 after finishing the procedure, 6 and 12 months post-operatively)
|
1 year
|
Esthetic evaluation (The pink esthetic score)
Time Frame: 1 year
|
The pink esthetic score will be calculated on the parameters defined by (Fürhauser et al. 2005).
Clinical photographs will be taken to evaluate peri-implant soft tissue through evaluating seven variables compared to a natural reference tooth including: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft- tissue color and texture.
Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value.
The maximum achievable PES is 14.
|
1 year
|
Implant stability
Time Frame: 6 months
|
implant stability will be measured using Ostell which has a scale ranges from 1 to 100, the higher the ISQ the more stability
|
6 months
|
Post-Operative patient's Satisfaction
Time Frame: 1 year
|
Three Yes or No Questions will be asked to the patient about his overall satisfaction about the procedure
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
- 2623
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
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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