Comparison of Peri Implant Soft Tissue Esthetics With Immediate Temporization With and Without Subepithelial Connective Tissue Graft

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.

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

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).