Immediate Temporization and Soft Tissue Augmentation Around Delayed Implants
Conditions
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
Interventions
PROCEDUREdelayed 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
PROCEDUREdelayed implant placement with immediate provisionalization
delayed implant placement with immediate provisionalization
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age \> 18 years old 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
1. Any known disease (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation; 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pink Esthetic Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction by Visual analogue scale (VAS) | 3 months post definitive | Patient satisfaction will be evaluated using a questionnaire which is based on a visual analog scale (VAS). A horizontal VAS bar, 100 mm long, with the right anchor labeled much less than natural teeth which is marked by zero and the left anchor labeled much more which is marked by 10 will be used. Five questions will be formulated to record the patients' satisfaction in terms of functionality and from an esthetic point of view. Participants will look in a mirror and also be viewed a photograph before recording their answers on the horizontal calibrated line. |
| Buccal peri-implant soft tissue thickness | 3 months post definitive | the soft tissue thickness buccal to the implant by using an anesthesia needle and digital caliper |
| Recession of the buccal peri-implant mucosa | 3 months post definitive | measured at the apical zenith of the mucosal margin on the implants after digital superimposition of the optically scanned models as the vertical distance change between the former and the new position of soft tissue margins. |
Countries
Egypt
Contacts
Primary ContactDina Osama, Bachelor
Backup ContactHany ElNahass, PHD
Outcome results
None listed