Variation of Keratinized Mucosa After Implant Surgery
Conditions
Keywords
dental implant, Keratinized mucosa, Connective tissue graft, flapless implant placement, Computer guided implantology, Immediate loading
Brief summary
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.
Interventions
PROCEDUREConnective tissue graft
Implants will be placed with a flap and a connective tissue graft.
PROCEDUREFlapless
Implants will be placed with a flapless approach
Sponsors
University of Milan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
surgical treatment will be conducted with surgeon-investigator and patient unblinded. the outcome assessor will be blinded as primary outcome measurements will be taken on a computer.
Intervention model description
two groups will be compared with different treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Widht of Keratinized mucosa | 2-4-8-12-24 weeks - 1-2-3-4-5 years | variation of keratized mucosa from t0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| marginal bone loss | 1-2-3-4-5 years | variation of marginal bone loss over time |
| Vas Scale | 2 weeks | Prom: patient VAS scale for post-operative pain, from 0 to 10, where 10 is higher and 0 is minimum. |
| implant survival | 1-2-3-4-5 years | Implant in function |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time | day 1 | surgical time differences between the two groups |
| prosthetic complications | 1-2-3-4-5 years | number and type of prosthetic complications over time |
Countries
Italy
Outcome results
None listed