Periodontal DiseasesNCT06253910

Comparison of Free Gingival Graft and Modified Apical Repositioning Flap Techniques

A study testing Patients selection and Recall visits in people with Periodontal Diseases, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Attached gingiva, a crucial component of the keratinized tissue, plays a vital role in preserving periodontal health. The free gingival graft (FGG) and modified apically repositioned flap (MARF) techniques are frequently used for addressing issues related to insufficient attached gingiva. Read more about this study

Who is it for?: Ages 34 to 58 years, women onlyHealthy volunteers can take part
Conditions the study is for: Periodontal Diseases
What is being tested?: Patients selection and Recall visits
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Feb 2019to 1 Dec 2023
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 34 to 58 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

having ≥15 permanent teeth excluding third molars,
not using any orthodontic appliance,
not being pregnant or breastfeeding,
not having any uncontrolled chronic and/or auto-immune disease,
not smoking.

Who cannot join

having chronic and/or auto-immune disease
smoking.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul Medipol University, School of Dentistry
Istanbul, Fatih, 34083

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Free Gingival Graft and Modified Apical Repositioning Flap Techniques to Create Attached Gingiva: A Long-Term (2 Year) Retrospective Study

Read the detailed description

The study included 15 participants who were both systemically and periodontally healthy, and these participants had a total of 21 teeth (10 for SDG and 11 for MARF). All included teeth had an attached gingiva width ranging from 0.5 mm to 1.5 mm and showed no signs of bone dehiscence. SDG and MARF methods were selected randomly (coin-to-coin). Clinical parameters recorded at baseline, third month, at first and second years were plaque index (PI), pocket probing depth (PPD), keratinized tissue width (KTW), attached gingiva width (AGW), bleeding on probing (BOP), gingival recession (GR) and clinical attachment level (CAL).

Conditions: Periodontal Diseases
Being tested: Patients selection, Recall visits
Keywords: attached gingiva, free gingival graft
Medical subject headings: Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patients selectionOther
Patient selection were selected according to selected criteria.
Recall visitsOther
Following the operations, periodontal measurements were measured at the baseline, third month, first and second years.

Study groups in NCT06253910
Study group	Role	What they receive
Patient selection	Other	A total of 15 (female) patients, between 31 and 70 years, who were systemically and periodontally healthy and applied to the periodontology clinic for treatment, were included in our study. Criteria for inclusion in the study are having ≥15 permanent teeth excluding third molars, not using any orthodontic appliance, not being pregnant or breastfeeding, not having any uncontrolled chronic and/or auto-immune disease, and not smoking. Receives: Other: Patients selection
MARF and FGG tehcniques	Other	Free gingival graft for the treatment of a total of 21 teeth with gingival recession in the lower jaw incisors area, no bone dehiscence, and the amount of attached gingiva being at least 0.5 mm and at most 1.5 mm and modified apically positioned flap methods were randomly selected (coin toss) and applied by a single investigator (MY). Surgical methods were performed on a minimum of 1 and a maximum of 2 teeth in the treated areas. Receives: Other: Patients selection
Post-surgical evalution and periodontal measurements	Other	Clinical periodontal parameters (plaque index (PI), pocket probing depth (PPD), bleeding on probing (BOP), gingival recession (GR) and clinical attachment level (CAL)) were recorded and evaluated at baseline, third months, first and second years. Periodontal measurements (keratinized tissue width (KTW), attached gingiva width (AGW)) recorded and evaluated at baseline, third months, first and second years. Receives: Other: Recall visits

What is being measured

The primary outcome is the main question the study is designed to answer.

Attached gingiva width
The width of the attached gingiva was calculated by measuring the distance from the crest of the gingival margin to the mucogingival junction and then subtracting the probing depth of the gingival sulcus from this distance on the particular tooth.
Measured: Baseline, third month, first year and second years.
Keratinized tissue width
The width of the keratinized tissue was calculated by measuring the distance from the crest of the gingival margin to the mucogingival junction
Measured: Baseline, third month, first year and second years.

Secondary outcomes (1)

Pocket probing depth
Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.
Measured: Baseline, third month, first year and second years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 20191 Dec 2023

First posted12 Feb 2024
Study start15 Feb 2019
Primary completion22 Nov 2022
Study completion1 Dec 2023

Why it stopped: waiting for re-calls

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Periodontal DiseasesStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06253910
Sponsor's protocol ID: 79
Status last verified: Feb 2024
First submitted: 2 Feb 2024
Last updated: 13 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: IPD will not be shared

Publications

Carnio J, Camargo PM, Klokkevold PR, Pirih FQ. The Modified Apically Repositioned Flap Technique: A Long-Term (4 to 16 Years) Retrospective Study. Int J Periodontics Restorative Dent. 2018 July/August;38(4):519-524. doi: 10.11607/prd.3028. Epub 2017 Dec 15.
PubMed 29244886
Carnio J, Carnio AT, Pirih FQ, Cordero MG, Camargo PM. The Modified Apically Repositioned Flap Technique and Its Potential to Create Attached Gingiva in Areas with No Keratinized Tissue: A Long-Term (1 to 11 Years) Retrospective Case Series Study. Int J Periodontics Restorative Dent. 2020 Jan/Feb;40(1):103-109. doi: 10.11607/prd.4241.
PubMed 31815979

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Periodontal Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Free Gingival Graft and Modified Apical Repositioning Flap Techniques to Create Attached Gingiva: A Long-Term (2 Year) Retrospective Study
ClinicalTrials.gov ID: NCT06253910
Acronym / sponsor ID: 79
Conditions: Periodontal Diseases
Keywords: attached gingiva, free gingival graft
Study type: Interventional
Recruitment status: TerminatedReason stopped: waiting for re-calls
Enrolment: 15 participants (actual)
Lead sponsor: Istanbul Medipol University HospitalUniversity, hospital or other
Study start: 15 Feb 2019 (actual)
Primary completion: 22 Nov 2022 (actual)
Study completion: 1 Dec 2023 (actual)
First posted: 12 Feb 2024 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Patient selection	Other	Other: Patients selectionA total of 15 (female) patients, between 31 and 70 years, who were systemically and periodontally healthy and applied to the periodontology clinic for treatment, were included in our study. Criteria for inclusion in the study are having ≥15 permanent teeth excluding third molars, not using any orthodontic appliance, not being pregnant or breastfeeding, not having any uncontrolled chronic and/or auto-immune disease, and not smoking.
MARF and FGG tehcniques	Other	Other: Patients selectionFree gingival graft for the treatment of a total of 21 teeth with gingival recession in the lower jaw incisors area, no bone dehiscence, and the amount of attached gingiva being at least 0.5 mm and at most 1.5 mm and modified apically positioned flap methods were randomly selected (coin toss) and applied by a single investigator (MY). Surgical methods were performed on a minimum of 1 and a maximum of 2 teeth in the treated areas.
Post-surgical evalution and periodontal measurements	Other	Other: Recall visitsClinical periodontal parameters (plaque index (PI), pocket probing depth (PPD), bleeding on probing (BOP), gingival recession (GR) and clinical attachment level (CAL)) were recorded and evaluated at baseline, third months, first and second years. Periodontal measurements (keratinized tissue width (KTW), attached gingiva width (AGW)) recorded and evaluated at baseline, third months, first and second years.

Who may qualify

Ages: 34 to 58 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

having ≥15 permanent teeth excluding third molars,
not using any orthodontic appliance,
not being pregnant or breastfeeding,
not having any uncontrolled chronic and/or auto-immune disease,
not smoking.

Key exclusion criteria (2 listed)

having chronic and/or auto-immune disease
smoking.

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
Patients selectionPatient selection were selected according to selected criteria.	Other	MARF and FGG tehcniques, Patient selection
Recall visitsFollowing the operations, periodontal measurements were measured at the baseline, third month, first and second years.	Other	Post-surgical evalution and periodontal measurements

Primary outcome

Attached gingiva width
Time frame: Baseline, third month, first year and second years.
The width of the attached gingiva was calculated by measuring the distance from the crest of the gingival margin to the mucogingival junction and then subtracting the probing depth of the gingival sulcus from this distance on the particular tooth.
Keratinized tissue width
Time frame: Baseline, third month, first year and second years.
The width of the keratinized tissue was calculated by measuring the distance from the crest of the gingival margin to the mucogingival junction

1 secondary outcome

Pocket probing depth
Time frame: Baseline, third month, first year and second years.

Results and safety

The study was stopped early (reason given: waiting for re-calls). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
Background: PubMed 29244886Carnio J, Camargo PM, Klokkevold PR, Pirih FQ. The Modified Apically Repositioned Flap Technique: A Long-Term (4 to 16 Years) Retrospective Study. Int J Periodontics Restorative Dent. 2018 July/August;38(4):519-524. doi: 10.11607/prd.3028. Epub 2017 Dec 15.
Background: PubMed 31815979Carnio J, Carnio AT, Pirih FQ, Cordero MG, Camargo PM. The Modified Apically Repositioned Flap Technique and Its Potential to Create Attached Gingiva in Areas with No Keratinized Tissue: A Long-Term (1 to 11 Years) Retrospective Case Series Study. Int J Periodontics Restorative Dent. 2020 Jan/Feb;40(1):103-109. doi: 10.11607/prd.4241.
for discussionLink provided by the sponsor.
for discussionLink provided by the sponsor.
Individual participant dataSharing planned: No. IPD will not be shared

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Patients selection and Recall visits in people with Periodontal Diseases, run by Istanbul Medipol University Hospital 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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 13 Feb 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 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 was stopped early (reason given: waiting for re-calls). Results are not available in the source record.

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?

Attached gingiva width (time frame: Baseline, third month, first year and second years.). The study lists 2 primary outcomes in all. 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 NCT06253910, which also lists 2 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 13 Feb 2024.