Comparison of Peri-implant Soft Tissue Esthetics Around Single Delayed Implant With Immediate Provisionalization Placed in The Esthetic Zone With and Without Using Subepithelial Connective Tissue Graft: A Randomized Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Immediate Temporization and Soft Tissue Augmentation Around Delayed Implants
- Sponsor
- Cairo University
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Pink Esthetic Score
- Last Updated
- 7 years ago
Overview
Brief Summary
The aim of this study is to clinically evaluate peri-implant soft tissue esthetics around single delayed implants in the esthetic zone.
Detailed Description
To compare the efficacy of soft tissue augmentation on the peri-implant soft tissue esthetics along with immediate temporization to immediate temporization only. 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
Investigators
Dina Osama Abdelwahab Megahed
Resident
Cairo University
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years old
- •Good medical and psychological health
- •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
- •Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar) region
- •Willingness to sign the informed consent form
Exclusion Criteria
- •Any known disease (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation;
- •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;
- •Anticoagulant therapy with warfarin, clopidogrel, ticlopidine or once daily aspirin (more than 81 mg);
- •HIV or Hepatitis;
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
- •Alcoholism or chronic drug abuse;
- •Heavy smokers (\>10/cigarettes per day);
- •Lack of adequate primary stability at implant insertion that enables immediate provisionalization (insertion torque ca 30 Ncm).
Outcomes
Primary Outcomes
Pink Esthetic Score
Time Frame: 3 months post definitive prosthesis
Pink esthetic score evaluates the soft tissue esthetics around implant supported crowns. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14. 7 variables are measured: mesial and distal papillae being 0 if absent, 1 if incomplete and 2 if complete. Alveolar process, soft tissue level, contour, texture and color being 0 if major discrepancy, 1 if minor discrepancy and 2 if matches the contralateral
Secondary Outcomes
- Buccal peri-implant soft tissue thickness(3 months post definitive)
- Patient satisfaction by Visual analogue scale (VAS)(3 months post definitive)
- Recession of the buccal peri-implant mucosa(3 months post definitive)