Failure of Dental Implant Due to Lack of Attached GingivaNCT02904551
Gingival Augmentation Around Implants During Maintenance
A study testing Free gingival graft and Oral prophylaxis in people with Failure of Dental Implant Due to Lack of Attached Gingiva, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Failure of Dental Implant Due to Lack of Attached Gingiva
- What is being tested?
- Free gingival graft and Oral prophylaxis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced General Dentistry at UMB DS
Baltimore, Maryland, 21201
About this study
Official title: Free Gingival Grafts for Implants Exhibiting Lack of Keratinized Gingiva: a Prospective Controlled Randomized Clinical Study
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.
Read the 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.
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.
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.
- Being tested
- Free gingival graft, Oral prophylaxis
- Keywords
- prospective study, free gingival graft, keratinized gingiva, dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free gingival graftProcedure or surgery
Also called Experimental
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.
Oral prophylaxisProcedure or surgery
Also called Control
Oral prophylaxis is a regular dental cleaning. Titanium periodontal curette and superfloss were used on implant sites. Stainless steel periodontal curettes and a piezo scaler were used for natural teeth.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Free gingival grafts Receives: Procedure: Free gingival graft |
| Control | Active comparator | Oral prophylaxis Receives: Procedure: Oral prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the width of Keratinized Gingiva from baseline to 6, 12, 18 months
Measured: 6, 12, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startFeb 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failure of Dental Implant Due to Lack of Attached GingivaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se-Lim Oh, University of Maryland, Baltimore
- Investigators
- Se-Lim Oh, DMD, MS, Principal investigator, University of Maryland School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904551
- Sponsor's protocol ID
- HR-00051371
- Status last verified
- Aug 2019
- First submitted
- 9 Sep 2016
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: IPD will not be shared. The results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free Gingival Grafts for Implants Exhibiting Lack of Keratinized Gingiva: a Prospective Controlled Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT02904551
- Acronym / sponsor ID
- HR-00051371
- Keywords
- prospective study, free gingival graft, keratinized gingiva, dental implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Free gingival graftFree gingival grafts |
| Control | Active comparator | Procedure: Oral prophylaxisOral prophylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free gingival graftAlso: ExperimentalAfter 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. | Procedure or surgery | Experimental |
| Oral prophylaxisAlso: ControlOral prophylaxis is a regular dental cleaning. Titanium periodontal curette and superfloss were used on implant sites. Stainless steel periodontal curettes and a piezo scaler were used for natural teeth. | Procedure or surgery | Control |
Primary outcome
Changes in the width of Keratinized Gingiva from baseline to 6, 12, 18 months
Time frame: 6, 12, 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No. IPD will not be shared. The results will be published.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Se-Lim Oh, DMD, MS principal investigator
University of Maryland School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free gingival graft and Oral prophylaxis in people with Failure of Dental Implant Due to Lack of Attached Gingiva, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the width of Keratinized Gingiva from baseline to 6, 12, 18 months (time frame: 6, 12, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.