Patient Reported OutcomeNCT04813081
The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life
A study testing Free Gingival Graft in people with Patient Reported Outcome, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the quality of life of patients who underwent FGG surgery around the natural tooth and as a second surgery after the implant operation, in comparison with general oral health assesment index(GOHAI). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Reported Outcome
- What is being tested?
- Free Gingival Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2017to 4 Mar 2019
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smoking
- Teeth and implants with keratinized gingiva width <1 mm
- A healthy periodontal and peri-implant condition
- Patients who didn't have ever experience periodontal surgery had first oral surgery experience with dental FGG operation for the first time
- Patients who underwent implant surgery for the first oral surgery experience
- Maximum two teeth/implants on recipient area
Who cannot join
- Patients receiving any medication to disrupt wound healing
- Lactation or pregnancy
- Caries or defects on the tooth root surface
- Periapical lesion in the recipient area active periodontal disease
- Patients who have previously had periodontal or oral surgery experiences
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Beykent University Faculty of Dentistry
Istanbul, 34500
About this study
Official title: The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life: Parallel-controlled Prospective Clinical Trial
The purpose of this study is to evaluate the quality of life of patients who underwent FGG surgery around the natural tooth and as a second surgery after the implant operation, in comparison with general oral health assesment index(GOHAI).
Read the detailed description
Thirty-two participants were included who were referred to the periodontology clinic suffering insufficient keratinized gingiva / mucosa deficiency around the implant and / or tooth/teeth. GOHAI-total and GOHAI psychological impact, functional limitation, pain and discomfort, behavioral impact subcategories were recorded at before and postoperative first week and 30th day. Also, satisfaction questionnaires, number of painkillers and visual analog scale values were recorded.
- Conditions
- Patient Reported Outcome
- Being tested
- Free Gingival Graft
- Keywords
- quality of life, graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free Gingival GraftProcedure or surgery
In the recipient area, a half-thickness flap with two vertical incision widths was removed with a horizontal incision with 15C blades from the mucogingival junction. The recipient site was determined such that one or two teeth or one tooth extends into the mesial and distal regions of the tooth. Muscle attachments were dissected and FGG was placed on recipient bed and non-resorbable monofilament sutures were used for fixing the four corners of the graft.
| Study group | Role | What they receive |
|---|---|---|
| Free gingival graft around dental implant patients | Active comparator | Test Group (TG) consists of patients have free gingival graft around dental implant patients Receives: Procedure: Free Gingival Graft |
| Free gingival graft around the teeth | Active comparator | Control Group (CG) consists of patients have free gingival graft around the teeth. Receives: Procedure: Free Gingival Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Oral Health Assesment Index (GOHAI) scores- intragroup comparisons change between from baseline to other follow-up times and intergroup comparisons all follow-up times
The questions that contains 12 items and that give subcategorized about functional limitations, pain and discomfort, psychological impacts, and behavioral impact.
Measured: Baseline, postoperative 1., 2., 3., 4., 5., 6. and 7. days and first month.
Secondary outcomes (1)
Age
18-65 years
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 May 2017
- Primary completion31 Jan 2019
- Study completion4 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Patient Reported OutcomeStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The participants were defined as two study groups: Test Group (TG) consists of patients have free gingival graft around dental implant patients and Control Group (CG) consists of patients have free gingival graft around the teeth.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Collaborators
- Kutahya Health Sciences University, Istanbul Aydın University
- Responsible party
- Principal investigator, Serap Karakış Akcan, University of Beykent
- Investigators
- serap karakış akcan, phd, Study director, Beykent Universityberceste güler, phd, Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813081
- Sponsor's protocol ID
- B.30.2.AYD.0.00.00-480.2/184
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zucchelli G, Tavelli L, McGuire MK, Rasperini G, Feinberg SE, Wang HL, Giannobile WV. Autogenous soft tissue grafting for periodontal and peri-implant plastic surgical reconstruction. J Periodontol. 2020 Jan;91(1):9-16. doi: 10.1002/JPER.19-0350. Epub 2019 Oct 6.
PubMed 31461778Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
PubMed 29926491McGuire MK, Scheyer ET, Gwaltney C. Commentary: incorporating patient-reported outcomes in periodontal clinical trials. J Periodontol. 2014 Oct;85(10):1313-9. doi: 10.1902/jop.2014.130693. Epub 2014 Jul 18.
PubMed 25034790Locker D, Matear D, Stephens M, Lawrence H, Payne B. Comparison of the GOHAI and OHIP-14 as measures of the oral health-related quality of life of the elderly. Community Dent Oral Epidemiol. 2001 Oct;29(5):373-81. doi: 10.1034/j.1600-0528.2001.290507.x.
PubMed 11553110Mei CC, Lee FY, Yeh HC. Assessment of pain perception following periodontal and implant surgeries. J Clin Periodontol. 2016 Dec;43(12):1151-1159. doi: 10.1111/jcpe.12618. Epub 2016 Nov 2.
PubMed 27554366
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life: Parallel-controlled Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT04813081
- Acronym / sponsor ID
- B.30.2.AYD.0.00.00-480.2/184
- Conditions
- Patient Reported Outcome
- Keywords
- quality of life, graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Collaborators
- Kutahya Health Sciences University, Istanbul Aydın University
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 4 Mar 2019 (actual)
- First posted
- 24 Mar 2021 (actual)
- 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.
The purpose of this study is to evaluate the quality of life of patients who underwent FGG surgery around the natural tooth and as a second surgery after the implant operation, in comparison with general oral health assesment index(GOHAI).
Detailed description
Thirty-two participants were included who were referred to the periodontology clinic suffering insufficient keratinized gingiva / mucosa deficiency around the implant and / or tooth/teeth. GOHAI-total and GOHAI psychological impact, functional limitation, pain and discomfort, behavioral impact subcategories were recorded at before and postoperative first week and 30th day. Also, satisfaction questionnaires, number of painkillers and visual analog scale values were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants were defined as two study groups: Test Group (TG) consists of patients have free gingival graft around dental implant patients and Control Group (CG) consists of patients have free gingival graft around the teeth.
| Arm | Type | Receives |
|---|---|---|
| Free gingival graft around dental implant patients | Active comparator | Procedure: Free Gingival GraftTest Group (TG) consists of patients have free gingival graft around dental implant patients |
| Free gingival graft around the teeth | Active comparator | Procedure: Free Gingival GraftControl Group (CG) consists of patients have free gingival graft around the teeth. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-smoking
- Teeth and implants with keratinized gingiva width <1 mm
- A healthy periodontal and peri-implant condition
- Patients who didn't have ever experience periodontal surgery had first oral surgery experience with dental FGG operation for the first time
- Patients who underwent implant surgery for the first oral surgery experience
Key exclusion criteria (5 listed)
- Patients receiving any medication to disrupt wound healing
- Lactation or pregnancy
- Caries or defects on the tooth root surface
- Periapical lesion in the recipient area active periodontal disease
- Patients who have previously had periodontal or oral surgery experiences
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 GraftIn the recipient area, a half-thickness flap with two vertical incision widths was removed with a horizontal incision with 15C blades from the mucogingival junction. The recipient site was determined such that one or two teeth or one tooth extends into the mesial and distal regions of the tooth. Muscle attachments were dissected and FGG was placed on recipient bed and non-resorbable monofilament sutures were used for fixing the four corners of the graft. | Procedure or surgery | Free gingival graft around dental implant patients, Free gingival graft around the teeth |
Primary outcome
General Oral Health Assesment Index (GOHAI) scores- intragroup comparisons change between from baseline to other follow-up times and intergroup comparisons all follow-up times
Time frame: Baseline, postoperative 1., 2., 3., 4., 5., 6. and 7. days and first month.
The questions that contains 12 items and that give subcategorized about functional limitations, pain and discomfort, psychological impacts, and behavioral impact.
1 secondary outcome
Age
Time frame: baseline
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 24 Mar 2021.
- Results publication: PubMed 31461778Zucchelli G, Tavelli L, McGuire MK, Rasperini G, Feinberg SE, Wang HL, Giannobile WV. Autogenous soft tissue grafting for periodontal and peri-implant plastic surgical reconstruction. J Periodontol. 2020 Jan;91(1):9-16. doi: 10.1002/JPER.19-0350. Epub 2019 Oct 6.
- Results publication: PubMed 29926491Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
- Results publication: PubMed 25034790McGuire MK, Scheyer ET, Gwaltney C. Commentary: incorporating patient-reported outcomes in periodontal clinical trials. J Periodontol. 2014 Oct;85(10):1313-9. doi: 10.1902/jop.2014.130693. Epub 2014 Jul 18.
- Results publication: PubMed 11553110Locker D, Matear D, Stephens M, Lawrence H, Payne B. Comparison of the GOHAI and OHIP-14 as measures of the oral health-related quality of life of the elderly. Community Dent Oral Epidemiol. 2001 Oct;29(5):373-81. doi: 10.1034/j.1600-0528.2001.290507.x.
- Results publication: PubMed 27554366Mei CC, Lee FY, Yeh HC. Assessment of pain perception following periodontal and implant surgeries. J Clin Periodontol. 2016 Dec;43(12):1151-1159. doi: 10.1111/jcpe.12618. Epub 2016 Nov 2.
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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.
serap karakış akcan, phd study director
Beykent University
berceste güler, phd principal investigator
Kutahya Health Sciences University
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 in people with Patient Reported Outcome, run by University of Beykent at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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 24 Mar 2021. 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 Turkey (Türkiye). 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?
General Oral Health Assesment Index (GOHAI) scores- intragroup comparisons change between from baseline to other follow-up times and intergroup comparisons all follow-up times (time frame: Baseline, postoperative 1., 2., 3., 4., 5., 6. and 7. days and first month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04813081, which also lists 5 linked publications.
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 24 Mar 2021.