Keratized Mucosa in CG Implant Placement: CTG vs Flapless | NCT05073952

Studies
Keratized Mucosa in CG Implant Placement: CTG vs Flapless

NCT05073952

Sponsor

University of Milan

Status

Recruiting

Last Update Posted

Dec 3, 2021Actual

Enrollment

44Estimated

Phase

Not Applicable

Conditions

Variation of Keratinized Mucosa After Implant Surgery

Interventions

Connective tissue graft
Flapless

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 18, 2021Actual

Primary Completion Date

Jun 1, 2023Estimated

Completion Date

Jun 1, 2028Estimated

First Submitted Date

Sep 17, 2021

First Submission Date that Met QC Criteria

Oct 11, 2021

First Posted Date

Oct 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2021

Last Update Posted Date

Dec 3, 2021Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Connective tissue graft	Procedure	Implants will be placed with a flap and a connective tissue graft.	Connective tissue graft

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Time	surgical time differences between the two groups	day 1
prosthetic complications	number and type of prosthetic complications over time

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided