Keratized Mucosa in CG Implant Placement: CTG vs Flapless

Study Overview
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Brief Summary
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The present study will evaluate the difference in terms of keratinazed mucosa (KM) in computer guided implant placement with immediate loading, comparing a flapless approach to flap surgery with connective tissue graft.

Official Title
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Width of Keratinazed Mucosa in Immediately Loaded Posterior Implant Restorations Treated With Different Surgical Approaches: Randomized Clinical Study.

Conditions
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Variation of Keratinized Mucosa After Implant Surgery

Intervention / Treatment
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* Procedure: Connective tissue graft
* Procedure: Flapless


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18+ Patients with partial edentulism in the posterior region (4-7) upper or lower for at least 3 months Patient whose tomographic examination shows adequate bone volumes for computer guided placement of a standard diameter implant (> 3.5 mm) without the need for bone regeneration procedures Patients who have accepted informed consent and participation in the study Patients who do not have exclusion criteria Eclusion Criteria Patients who refuse to co-operate Systemic conditions of exclusion: Medical conditions requiring prolonged use of steroids Severe hemophilia In therapy with intravenous bisphosphonates History of white blood cell dysfunction or deficiency History of head and neck radiotherapy or chemotherapy History of kidney failure Pregnant or breastfeeding patient History of uncontrolled endocrine disorders Physical handicaps that hinder proper oral hygiene Use of experimental devices or drugs within 30 days prior to implant placement surgery Alcoholism or drug abuse Smokers of> 10 cigarettes per day or the equivalent cigar or> 10 tobacco-based chewings per day Conditions or circumstances that prevent the completion of participation in the study or interfere with the analysis of the study results Local exclusion conditions: Local inflammation, including untreated periodontitis Patients with erosive lichen planus History of local radiation therapy Presence of bone lesions Unhealed extraction sites History of bone reconstruction and bone grafting techniques in the sites where the implants are to be inserted Bruxism Bleeding index> 30% and number of pockets> 5mm greater than 10

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two groups will be compared with different treatment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Connective tissue graft<br>patient in this group will be treated with a flap and a connective tissue graft at the moment of implant placement. | Procedure: Connective tissue graft<br>* Implants will be placed with a flap and a connective tissue graft.<br>|
| Active Comparator: Flapess<br>patient in this group will be treated with a flapless approach at the moment of implant placement. | Procedure: Flapless<br>* Implants will be placed with a flapless approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Widht of Keratinized mucosa | variation of keratized mucosa from t0 | 2-4-8-12-24 weeks - 1-2-3-4-5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant survival | Implant in function | 1-2-3-4-5 years | 
| marginal bone loss | variation of marginal bone loss over time | 1-2-3-4-5 years | 
| Vas Scale | Prom: patient VAS scale for post-operative pain, from 0 to 10, where 10 is higher and 0 is minimum. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implant, Keratinized mucosa, Connective tissue graft, flapless implant placement, Computer guided implantology, Immediate loading