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Recruiting NCT05073952

Keratized Mucosa in CG Implant Placement: CTG vs Flapless

No phase Interventional Variation of Keratinized Mucosa After Implant Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Connective tissue graft, Flapless.
Who it may be relevant to
Registry conditions: Variation of Keratinized Mucosa After Implant Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure Connective tissue graft
    Implants will be placed with a flap and a connective tissue graft.
  • Procedure Flapless
    Implants will be placed with a flapless approach

Primary outcome measures

  • Widht of Keratinized mucosa [Time frame: 2-4-8-12-24 weeks - 1-2-3-4-5 years]
Secondary outcome measures (3)
  • implant survival [Time frame: 1-2-3-4-5 years]
  • marginal bone loss [Time frame: 1-2-3-4-5 years]
  • Vas Scale [Time frame: 2 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Italy · 1 center
  • Clinica Odontoiatrica Giorgio Vogel — Milan

Identifiers

NCT: NCT05073952 · KM001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗