Clinical trial NCT05073952: Keratized Mucosa in CG Implant Placement: CTG vs Flapless
Official title: Width of Keratinazed Mucosa in Immediately Loaded Posterior Implant Restorations Treated With Different Surgical Approaches: Randomized Clinical Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Variation of Keratinized Mucosa After Implant Surgery
Keywords: dental implant
Keratinized mucosa
Connective tissue graft
flapless implant placement
Computer guided implantology
Immediate loading
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups will be compared with different treatment
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Widht of Keratinized mucosa
timeFrame: 2-4-8-12-24 weeks - 1-2-3-4-5 years
Secondary outcomes:
measure: implant survival
timeFrame: 1-2-3-4-5 years
measure: marginal bone loss
timeFrame: 1-2-3-4-5 years
measure: Vas Scale
timeFrame: 2 weeks
Other outcomes:
measure: Time
timeFrame: day 1
measure: prosthetic complications
timeFrame: 1-2-3-4-5 years
Locations:
city: Milan
country: Italy
facility: Clinica Odontoiatrica Giorgio Vogel
state: MI
Study officials:
References: