Keratized Mucosa in CG Implant Placement: CTG vs Flapless

NCT05073952 | Recruiting

• 1 other identifier: KM001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Variation of Keratinized Mucosa After Implant Surgery

Keywords

dental implant; Keratinized mucosa; Connective tissue graft; flapless implant placement; Computer guided implantology; Immediate loading

Outcome Measures

Primary Outcomes (1)

• Widht of Keratinized mucosa

  variation of keratized mucosa from t0

  2-4-8-12-24 weeks - 1-2-3-4-5 years

Secondary Outcomes (3)

• implant survival

  1-2-3-4-5 years

• marginal bone loss

  1-2-3-4-5 years

• Vas Scale

  2 weeks

Other Outcomes (2)

• Time

  day 1

• prosthetic complications

  1-2-3-4-5 years

Study Arms (2)

Connective tissue graft

ACTIVE COMPARATOR

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

Flapess

ACTIVE COMPARATOR

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

Procedure: Flapless

Interventions

Connective tissue graft PROCEDURE

Implants will be placed with a flap and a connective tissue graft.

Connective tissue graft

Flapless PROCEDURE

Implants will be placed with a flapless approach

Flapess

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Eclusion Criteria
• Patients who refuse to co-operate
• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Clinica Odontoiatrica Giorgio Vogel

Milan, MI, 20142, Italy

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: surgical treatment will be conducted with surgeon-investigator and patient unblinded. the outcome assessor will be blinded as primary outcome measurements will be taken on a computer.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reasearcher

Model Details: two groups will be compared with different treatment

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 12, 2021
• Study Start: October 18, 2021
• Primary Completion: June 1, 2023
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 3, 2021

Record last verified: 2021-12

Locations

IT (1)