Keratized Mucosa in CG Implant Placement: CTG vs Flapless

ConditionVariation of Keratinized Mucosa After Implant Surgery

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Milan

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Patients who refuse to co-operate

Medical conditions requiring prolonged use of steroids

Severe hemophilia

In therapy with intravenous bisphosphonates

Trial design

Design model

Parallel

Treatments tested in this trial

Connective tissue graft
Procedure/Surgery
Implants will be placed with a flap and a connective tissue graft.
Flapless
Procedure/Surgery
Implants will be placed with a flapless approach

Treatment groups

44 Participants

are divided into 2 treatment groups

Group A: Connective tissue graftActive comparator 1 intervention

Group B: FlapessActive comparator 1 intervention

Trial outcomes

Primary outcomes

Widht of Keratinized mucosa

variation of keratized mucosa from t0

Time frame

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

Secondary outcomes

implant survival

Implant in function

Time frame

1-2-3-4-5 years

marginal bone loss

variation of marginal bone loss over time

Time frame

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.

Time frame

2 weeks

Other outcomes

Time

surgical time differences between the two groups

Time frame

day 1

prosthetic complications

number and type of prosthetic complications over time

Time frame

1-2-3-4-5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Milan

Lead sponsor

Source ClinicalTrials.gov

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