Keratized Mucosa in CG Implant Placement: CTG vs Flapless

Not Applicable

Recruiting

• Conditions: Variation of Keratinized Mucosa After Implant Surgery
• Interventions: Procedure: Flapless; Procedure: Connective tissue graft

• Registration Number: NCT05073952
• Lead Sponsor: University of Milan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-12
• Study Start: 2021-10-18
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-03
• Primary Completion: 2023-06-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flapess	Flapless	patient in this group will be treated with a flapless approach at the moment of implant placement.
Connective tissue graft	Connective tissue graft	patient in this group will be treated with a flap and a connective tissue graft at the moment of implant placement.

Primary Outcome Measures

Name	Time	Method
Widht of Keratinized mucosa	2-4-8-12-24 weeks - 1-2-3-4-5 years	variation of keratized mucosa from t0

Secondary Outcome Measures

Name	Time	Method
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
marginal bone loss	1-2-3-4-5 years	variation of marginal bone loss over time

Trial Locations

Locations (1)

Clinica Odontoiatrica Giorgio Vogel; 🇮🇹 Milan, MI, Italy