Comparison of Peri Implant Soft Tissue Esthetics With Immediate Temporization With and Without Subepithelial Connective Tissue Graft
NCT ID: NCT03770975
Last Updated: 2018-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
22 participants
INTERVENTIONAL
2018-12-01
2020-05-01
Brief Summary
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Detailed Description
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Population (P): patients with a single missing tooth in the esthetic zone Intervention (I): Delayed implant placement with immediate temporization and subepithelial connective tissue graft Comparator (C): Delayed implant placement with immediate temporization Primary outcome: Pink esthetic score (PES) Time frame: 6 months Study design: Randomized controlled clinical trial
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Delayed implant placement with immediate provisionalization
Single delayed implant placement in the esthetic zone with placing an immediate temporary crown placed within 48 hours after the surgery
delayed implant with immediate provisionaliztion and soft tissue graft
delayed implant placement in the esthetic zone with immediate provisinalization and placement of a connective tissue graft buccal
Implant with immediate temporization and soft tissue graft
Single delayed implant placement in the esthetic zone with placing a subepithelial connective tissue graft buccal to the implant and immediate temporary crown within 48 hours after the surgery
delayed implant placement with immediate provisionalization
delayed implant placement with immediate provisionalization
Interventions
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delayed implant with immediate provisionaliztion and soft tissue graft
delayed implant placement in the esthetic zone with immediate provisinalization and placement of a connective tissue graft buccal
delayed implant placement with immediate provisionalization
delayed implant placement with immediate provisionalization
Eligibility Criteria
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Inclusion Criteria
2. Good medical and psychological health
3. Absence of untreated caries lesions and untreated/uncontrolled periodontal disease. If patients required periodontal treatment (non-surgical and/or surgical), this was arranged outside the study protocol and completed at least 30 days prior to the enrolment
4. Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar) region
5. Willingness to sign the informed consent form
Exclusion Criteria
2. Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) within 1 month before baseline visit;
3. Anticoagulant therapy with warfarin, clopidogrel, ticlopidine or once daily aspirin (more than 81 mg);
4. HIV or Hepatitis;
5. Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
6. Alcoholism or chronic drug abuse;
7. Heavy smokers (\>10/cigarettes per day);
8. Lack of adequate primary stability at implant insertion that enables immediate provisionalization (insertion torque ca 30 Ncm).
18 Years
60 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Dina Osama Abdelwahab Megahed
Resident
Principal Investigators
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Azza Ezz AlArab, PHD
Role: STUDY_CHAIR
Professor in the department of Oral Medicine and Periodontology
Locations
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Faculty of Dentistry, Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Hany ElNahass, PHD
Role: primary
References
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Abdelwahab D, Ezz AlArab A, El Nahass H. Soft tissue esthetics around immediately provisionalized delayed implants with and without connective tissue graft: A randomized clinical trial pilot study. Clin Implant Dent Relat Res. 2023 Feb;25(1):11-22. doi: 10.1111/cid.13168. Epub 2022 Dec 29.
Other Identifiers
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Dinaosamaperio
Identifier Type: -
Identifier Source: org_study_id