Keratized Mucosa in CG Implant Placement: CTG vs Flapless

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

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.

Study Overview

• Status: Recruiting
• Conditions: Variation of Keratinized Mucosa After Implant Surgery
• Intervention / Treatment: Procedure: Connective tissue graft; Procedure: Flapless

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20142
      • Recruiting
      • Clinica Odontoiatrica Giorgio Vogel
      • Contact: Stefano Storelli, PHD; Phone Number: 0250319003; Email: stefano.storelli@unimi.it
      • Contact: Eugenio Romeo, Prof.; Phone Number: 0250319003; Email: eugenio.romeo@unimi.it
      • Principal Investigator: Stefano Storelli, PHD
      • Sub-Investigator: Eugenio Romeo, Prof.
      • Sub-Investigator: Giulia Palandrani, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Connective tissue graft; patient in this group will be treated with a flap and a connective tissue graft at the moment of implant placement.	Procedure: Connective tissue graft; Implants will be placed with a flap and a connective tissue graft.
Active Comparator: Flapess; patient in this group will be treated with a flapless approach at the moment of implant placement.	Procedure: Flapless; Implants will be placed with a flapless approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Widht of Keratinized mucosa	variation of keratized mucosa from t0	2-4-8-12-24 weeks - 1-2-3-4-5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implant survival	Implant in function	1-2-3-4-5 years
marginal bone loss	variation of marginal bone loss over time	1-2-3-4-5 years
Vas Scale	Prom: patient VAS scale for post-operative pain, from 0 to 10, where 10 is higher and 0 is minimum.	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time	surgical time differences between the two groups	day 1
prosthetic complications	number and type of prosthetic complications over time	1-2-3-4-5 years

Collaborators and Investigators

• Sponsor: University of Milan

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2028

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: dental implant; Connective tissue graft; Keratinized mucosa; flapless implant placement; Computer guided implantology; Immediate loading
• Other Study ID Numbers: KM001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No