Gingival Augmentation Around Implants During Maintenance | NCT02904551

Studies
Gingival Augmentation Around Implants During Maintenance

NCT02904551

Sponsor

University of Maryland, Baltimore

Status

Completed

Last Update Posted

Dec 11, 2024Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Failure of Dental Implant Due to Lack of Attached Gingiva

Interventions

Free gingival graft
Oral prophylaxis

Countries

United States

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

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Sep 9, 2016

First Submission Date that Met QC Criteria

Sep 16, 2016

First Posted Date

Sep 19, 2016Estimated

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 5, 2024

Last Update Posted Date

Dec 11, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Se-Lim Oh, Assistant Professor, University of Maryland, BaltimorePrincipal Investigator

Lead Sponsor

University of Maryland, BaltimoreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This prospective controlled randomized blind clinical study investigated 44 implants displaying lack of KG in 29 subjects. Fourteen subjects received FGGs followed by oral prophylaxis. Fifteen subjects in the control group did not receive FGGs. The width of KG, gingival recession (GR), pocket depths (PD), plaque index (PI) and gingival index (GI) were assessed at baseline, 6, 12, and 18 months. Changes in crestal bone levels, from baseline, were assessed at 18 months.

Detailed Description

The purpose of this study was to evaluate clinical and radiographic outcomes following free gingival grafts (FGGs) around implants with limited keratinized gingiva (KG) compared to oral prophylaxis without gingival augmentation.

There was a significant gain in KG with a reduction in GR in the FGG group compared to controls at 6, 12, and 18 months. The mean PI and GI were significantly lower for the FGG group at 12 and 18 months.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Free gingival grafts	Procedure: Free gingival graft
Control	Active Comparator	Oral prophylaxis	Procedure: Oral prophylaxis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Free gingival graft	Procedure	After infiltration anesthesia, a recipient bed was prepared with a horizontal split-thickness incision made with a 15 stainless steel blade at the mucogingival junction (MGJ) on the facial side of the selected implants. An intermediate thickness (0.75 mm) graft was taken from the palate. The graft was sutured with 6-0 polypropylene suture at the recipient site. Co-Pak® was applied on the recipient site. Analgesics (over-the-counter Tylenol or Ibuprofen) were prescribed for 5-7 days. PeridexTM (3M, St. Paul, MN) was prescribed for 7-10 days. No antibiotics were prescribed in relation to the surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in the width of Keratinized Gingiva from baseline to 6, 12, 18 months		6, 12, 18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

less than 2 mm KG present on the facial side of implant
implant restoration is single unsplinted unit, and has been in function for at least 6 months with an opposing dentition.

Exclusion Criteria:

uncontrolled hypertension
diabetes mellitus (DM),
subjects with a history of a long-term (>6 months) use of corticosteroid
subjects currently taking bisphosphonates, or with a history of taking bisphosphonates regardless of route of administration
subjects on medications that cause gingival hyperplasia
smokers
pregnant women.

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Se-Lim Oh, DMD, MS	University of Maryland School of Dentistry	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Advanced General Dentistry at UMB DS		Baltimore	Maryland	21201	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD will not be shared. The results will be published.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided