Free Mucogingival GraftsNCT05851248
Free Mucogingival Graft for Isolated Root Coverage
A study testing Buccal muco-gingival tissue graft and Palatal connective tissue graft in people with Free Mucogingival Grafts and Gingival Recession, run by Universidad de Murcia at 1 site in Spain.
Trial summary
The goal of this clinical trial is to to describe and evaluate an approach, free mucogingival graft (FMG), in periodontal plastic surgery for root coverage (RC) in lower incisor gingival recessions (GR) with mucogingival conditions and deformities (MCD) that might negatively influence the outcomes of conventional RC… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Free Mucogingival Grafts, Gingival Recession, Root Coverage
- What is being tested?
- Buccal muco-gingival tissue graft and Palatal connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jan 2023to 22 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy patients with deep GR associated with lower incisor MCD.
- Full mouth plaque and bleeding scores were <20%.
Who cannot join
- Patient characteristics:
- Smoking ≥10 cigarettes a day.
- Medications or systemic contraindications for oral surgery.
- Pregnancy.
- Defects:
- Thin scalloped biotype (AND/OR)
- Underlying bone dehiscence (AND /OR)
- Generalized GR affecting most sextants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Centro Odontologico Del Sureste Slp
Murcia, Murcia, 30007
Antonio J Ortiz-Ruiz, MD, +34 868888581, ajortiz@um.es
Jose A Moreno-Rodriguez, +34 620538483, joseantonio171087@hotmail.com
About this study
Official title: Free Mucogingival Graft for Isolated Root Coverage and Correct Unfavorable Mucogingival Conditions in Lower Incisors: A Randomized Clinical Trial
The goal of this clinical trial is to to describe and evaluate an approach, free mucogingival graft (FMG), in periodontal plastic surgery for root coverage (RC) in lower incisor gingival recessions (GR) with mucogingival conditions and deformities (MCD) that might negatively influence the outcomes of conventional RC procedures.
- Being tested
- Buccal muco-gingival tissue graft, Palatal connective tissue graft
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal muco-gingival tissue graftProcedure or surgery
Recipient Site Preparation. In the GR, a sulcular incision limited to the vestibular face will be made, which will continue until reaching the tip of the buccal papillae on each side of the GR. Two vertical incisions from the base of the two papillae to the bottom of the vestibule and one horizontal incision will connect the ends of both vertical incisions to remove the pedicle tissue. The exposed root surface will be cleaned and smoothed with mini-curettes.
Donor site preparation. The incisions will be made in the same way as in the recipient area, including both papillae. The vertical incision will measure the distance from the cementoenamel junction (CEJ) to the bony dehiscence in the GR tooth, plus at least 2 mm. The tissue between the incisions will be elevated fjull or partial thickness close to the bone in the keratinized portion and superficially in the mucosal portion. A soft tissue substitute will be adapted and sutured to protect the donor site.
Palatal connective tissue graftProcedure or surgery
Recipient Site Preparation. In the GR, a sulcular incision limited to the vestibular face will be made, which will continue until reaching the tip of the buccal papillae on each side of the GR. Two vertical incisions from the base of the two papillae to the bottom of the vestibule and one horizontal incision will connect the ends of both vertical incisions to remove the pedicle tissue. The exposed root surface will be cleaned and smoothed with mini-curettes.
Donor site preparation A connective tissue graft will be taken from the palatal area, at the level of the premolars, which will include the two papillae. The size of the graft will be the same as that of the recipient area. A soft tissue substitute will be adapted and sutured to protect the donor site, especially if there is exposed bone.
| Study group | Role | What they receive |
|---|---|---|
| Buccal muco-gingival tissue graft | Experimental | Not described Receives: Procedure: Buccal muco-gingival tissue graft |
| Palatal connective tissue graft | Active comparator | Not described Receives: Procedure: Palatal connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
buccal Recession (bREC)
Buccal recession measurement, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.
Measured: 12 months
Secondary outcomes (6)
buccal Clinical Attachment Level (bCAL)
bCAL will be assessed with a periodontal probe, measured in mm from the CEJ to the bottom of the pocket, on the buccal aspect.
Measured: 12 months
interproximal Clinical Attachment Level (iCAL)
iCAL will be assessed with a periodontal probe, measured in mm from the CEJ to the bottom of the pocket, on the interproximal aspect.
Measured: 12 months
Interproximal papilla tip location (PT)
Taking as reference the level of the mid-axis of the tooth, PT will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise.
This outcome will be assessed with a periodontal probe and measured in mmm.
Measured: 12 months
keratinized tissue width (KT)
KT will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.
Measured: 12 months
vestibule depth (VD)
VD will be measured, from the mucosal margin to the point of greatest concavity of the mucobuccal fold. The measure will be assessed with a periodontal probe in mm.
Measured: 12 months
Soft tissue attached to alveolar bone (STAB)
STAB will be measured from the gingival margen to the perpendicular mucosal insertion. The measure will be assessed with a periodontal probe in mm.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start2 Jan 2023
- Primary completion22 Dec 2026 (estimated)
- Study completion22 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free Mucogingival GraftsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio José Ortiz Ruiz, MD, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851248
- Sponsor's protocol ID
- 4157/2022
- Status last verified
- Feb 2026
- First submitted
- 25 Apr 2023
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free Mucogingival Graft for Isolated Root Coverage and Correct Unfavorable Mucogingival Conditions in Lower Incisors: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05851248
- Acronym / sponsor ID
- 4157/2022
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 22 Dec 2026 (estimated)
- Study completion
- 22 Apr 2027 (estimated)
- First posted
- 9 May 2023 (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 goal of this clinical trial is to to describe and evaluate an approach, free mucogingival graft (FMG), in periodontal plastic surgery for root coverage (RC) in lower incisor gingival recessions (GR) with mucogingival conditions and deformities (MCD) that might negatively influence the outcomes of conventional RC procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buccal muco-gingival tissue graft | Experimental | Procedure: Buccal muco-gingival tissue graft |
| Palatal connective tissue graft | Active comparator | Procedure: Palatal connective tissue graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy patients with deep GR associated with lower incisor MCD.
- Full mouth plaque and bleeding scores were <20%.
Key exclusion criteria (8 listed)
- Smoking ≥10 cigarettes a day.
- Medications or systemic contraindications for oral surgery.
- Pregnancy.
- Thin scalloped biotype (AND/OR)
- Underlying bone dehiscence (AND /OR)
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 |
|---|---|---|
| Buccal muco-gingival tissue graftRecipient Site Preparation. In the GR, a sulcular incision limited to the vestibular face will be made, which will continue until reaching the tip of the buccal papillae on each side of the GR. Two vertical incisions from the base of the two papillae to the bottom of the vestibule and one horizontal incision will connect the ends of both vertical incisions to remove the pedicle tissue. The exposed root surface will be cleaned and smoothed with mini-curettes. Donor site preparation. The incisions will be made in the same way as in the recipient area, including both papillae. The vertical incision will measure the distance from the cementoenamel junction (CEJ) to the bony dehiscence in the GR tooth, plus at least 2 mm. The tissue between the incisions will be elevated fjull or partial thickness close to the bone in the keratinized portion and superficially in the mucosal portion. A soft tissue substitute will be adapted and sutured to protect the donor site. | Procedure or surgery | Buccal muco-gingival tissue graft |
| Palatal connective tissue graftRecipient Site Preparation. In the GR, a sulcular incision limited to the vestibular face will be made, which will continue until reaching the tip of the buccal papillae on each side of the GR. Two vertical incisions from the base of the two papillae to the bottom of the vestibule and one horizontal incision will connect the ends of both vertical incisions to remove the pedicle tissue. The exposed root surface will be cleaned and smoothed with mini-curettes. Donor site preparation A connective tissue graft will be taken from the palatal area, at the level of the premolars, which will include the two papillae. The size of the graft will be the same as that of the recipient area. A soft tissue substitute will be adapted and sutured to protect the donor site, especially if there is exposed bone. | Procedure or surgery | Palatal connective tissue graft |
Primary outcome
buccal Recession (bREC)
Time frame: 12 months
Buccal recession measurement, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.
6 secondary outcomes
buccal Clinical Attachment Level (bCAL)
Time frame: 12 months
interproximal Clinical Attachment Level (iCAL)
Time frame: 12 months
Interproximal papilla tip location (PT)
Time frame: 12 months
keratinized tissue width (KT)
Time frame: 12 months
vestibule depth (VD)
Time frame: 12 months
Soft tissue attached to alveolar bone (STAB)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buccal muco-gingival tissue graft and Palatal connective tissue graft in people with Free Mucogingival Grafts and Gingival Recession, run by Universidad de Murcia at 1 site in Spain.
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 8 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: looking for participants now, as of the sponsor's last update on 19 Feb 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio J Ortiz-Ruiz, MD (+34 868888581, ajortiz@um.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
buccal Recession (bREC) (time frame: 12 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 19 Feb 2026.