Keratized Mucosa in CG Implant Placement: CTG vs Flapless

University of Milan

Status: Enrolling

Conditions: Variation of Keratinized Mucosa After Implant Surgery

Treatments: Procedure: Connective tissue graft; Procedure: Flapless

Study type: Interventional

Funder types: Other

Identifiers

NCT05073952

KM001

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

44 participants in 2 patient groups

Connective tissue graft

Active Comparator group

Description:

patient in this group will be treated with a flap and a connective tissue graft at the moment of implant placement.

Treatment:

Procedure: Connective tissue graft

Flapess

Active Comparator group

Description:

patient in this group will be treated with a flapless approach at the moment of implant placement.

Treatment:

Procedure: Flapless