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
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Cairo University
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Pink Esthetic Score
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Arms & Interventions
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
Intervention: delayed implant placement with immediate provisionalization (Procedure)
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
Intervention: delayed implant with immediate provisionaliztion and soft tissue graft (Procedure)
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)
Investigators
Dina Osama Abdelwahab Megahed
Resident
Cairo University