PES After Soft Tissue Augmentation Using CTG Around Immediate Dental Implants Versus Immediate Dental Implants Alone in Esthetic Zone
NCT ID: NCT03425864
Last Updated: 2021-06-18
Study Results
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Basic Information
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COMPLETED
NA
3 participants
INTERVENTIONAL
2017-07-11
2020-10-13
Brief Summary
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Detailed Description
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Considering the survival rate of immediate implantation versus delayed implantation there is no significant difference with an overall success rate of 99.6%, it is just considered as a successful treatment modality, based on 802 implants (5).
On the other hand disadvantage related to esthetic outcome has been reported, showing facial gingival recession following the first year of function due to labial bone plate resorption. (6, 2).
A systematic review by Sanz et al.,(2012) compared the reduction of bone height and bone width between two groups the control group was delayed implant placement and the studied group was immediate implant placement and the mean difference between groups was of 13.11% (95% CI: from 3.83 to 22.4; P = 0.057) and 19.85% (95% CI: from 13.85 to 25.81)respectively, concluding that the early placement of dental implants after tooth extraction offers advantages in terms of soft and hard tissue preservation, compared with delayed implant placement , which affect the aesthetic (7 ) As a sequence of dimensional ridge alterations that occur following tooth extraction many studies reported a recession of marginal peri-implant mucosa, which affect the aesthetic outcome (8, 9, and 10).
A study made by Migliorati et al., (2015) between two groups, the control group (immediate loading implant treated without raising a flap) and the test group (immediate loaded implant treated with sub-epithelial connective tissue graft (SCTG) using the tunnel technique in the labial area) Both groups (47 implants) received deproteinized bovine bone minerals and implants were successfully integrated with a follow up period 2-year examination . Moreover the mean recession in the control group was 0.71mm (17.58%), one third of the control group reported recession \>1mm, and mean pink aesthetic score (PES) was 6.65, resulting in bad aesthetic. The test group showed an increase of the keratinized mucosa (KM) with a mean of 34.29% (0.5mm) and a mean recession of 0.2mm (10.01%), only one case (4%) showed recession \>1mm and the mean PES was 8. The thickening of soft tissue by the addition of SCTG, lead to compensation and maintenance of the loss of bone volume in the labial area (11).
The addition of sub epithelial connective tissue graft (SCTG) to the immediate implant was suggested for facial gingival biotype conversation. It was proved to be successful in preserving soft tissue levels. (12)
A systematic review was made to investigate if the addition of SCTG overcome the disadvantage of placement of immediate implant only or not, but unfortunately the included studies had different techniques and the number of the patients in those studies was few thus further RCT was necessary (13).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Blinding of the biostatistian.
Study Groups
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immediate implant
patient will receive immediate implant alone.
immediate implant
patient will receive immediate implant with connective tissue graft.
immediate implant with connective tissue graft
patient will receive immediate implant and connective tissue gaft
connective tissue graft
patient will receive immediate implant and connective tissue graft
immediate implant
patient will receive immediate implant with connective tissue graft.
Interventions
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connective tissue graft
patient will receive immediate implant and connective tissue graft
immediate implant
patient will receive immediate implant with connective tissue graft.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1\. Age: 20-50. 2. Patients with single non-restorable teeth in anterior or premolar area. 3. "Patients with adequate bone volume for the dental implant procedure". 5. Patients who are compliant to oral hygiene measures. 6. Patient consent approval and signing.
Exclusion Criteria
2. Patients with any habits that might affect osseointegration, such as heavy smoking and alcoholism.
3. Pregnant women.
4. Patients with untreated periodontal disease or the presence of pathologic condition at implant site.
5. Patients with Parafunctional habits that produce overload on the implant such as bruxism and clenching.
6. Shallow palate.
20 Years
50 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Nada Farouk Hasan Abd El-Aziz
OTHER
Responsible Party
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Nada Farouk Hasan Abd El-Aziz
Assistant Specialist
Locations
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Nada Abd El Aziz
Minya, Minya Governorate, Egypt
Countries
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Other Identifiers
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2010
Identifier Type: -
Identifier Source: org_study_id
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