Immediate Temporization and Soft Tissue Augmentation Around Delayed Implants Clinical Trial
Official title:
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
The aim of this study is to clinically evaluate peri-implant soft tissue esthetics around single delayed implants in the esthetic zone.
| Status | Not yet recruiting |
| Enrollment | 22 |
| Est. completion date | May 1, 2020 |
| Est. primary completion date | December 1, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
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). |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Faculty of Dentistry, Cairo University | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Cairo University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pink Esthetic Score | 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 | 3 months post definitive prosthesis | |
| Secondary | Patient satisfaction by Visual analogue scale (VAS) | 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. | 3 months post definitive | |
| Secondary | Buccal peri-implant soft tissue thickness | the soft tissue thickness buccal to the implant by using an anesthesia needle and digital caliper | 3 months post definitive | |
| Secondary | Recession of the buccal peri-implant mucosa | 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. | 3 months post definitive |