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Keratized Mucosa in CG Implant Placement: CTG vs Flapless

NCT ID: NCT05073952

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-18

Study Completion Date

2028-06-01

Brief Summary

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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

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Conditions

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Variation of Keratinized Mucosa After Implant Surgery

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two groups will be compared with different treatment
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Connective tissue graft

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

Group Type ACTIVE_COMPARATOR

Connective tissue graft

Intervention Type PROCEDURE

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

Flapess

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

Group Type ACTIVE_COMPARATOR

Flapless

Intervention Type PROCEDURE

Implants will be placed with a flapless approach

Interventions

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Connective tissue graft

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

Intervention Type PROCEDURE

Flapless

Implants will be placed with a flapless approach

Intervention Type PROCEDURE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Milan

OTHER

Sponsor Role lead

Responsible Party

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Stefano Storelli

Reasearcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinica Odontoiatrica Giorgio Vogel

Milan, MI, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Stefano Storelli, PHD

Role: primary

Eugenio Romeo, Prof.

Role: backup

Other Identifiers

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KM001

Identifier Type: -

Identifier Source: org_study_id