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Gingival RecessionTOPGRAFTNCT03661619

Tuberosity Versus Palatal Donor Site for Subepithelial Connective Tissue Graft in Root Coverage Therapy (TOPGRAFT)

A study testing Sub-epithelial connective tissue graft harvested from the palatal for root coverage procedure and Sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedure in people with Gingival Recession, run by Assistance Publique - Hôpitaux de Paris.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Gingival recessions are characterized by the apical migration of the marginal gingivae toward the cemento-enamel junction. Our team in France reported that 84,6% of the population exhibited gingival recession. Other epidemiologic data report that 25% of an american population exhibit recessions deeper than 3mm. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gingival Recession
What is being tested?
Sub-epithelial connective tissue graft harvested from the palatal for root coverage procedure and Sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
No sites listed yet
Study dates
Oct 2018to Oct 2020
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females must be at least 18 years of age.
  • Patients must be in good general health without any systemic diseases.
  • Presence of buccal gingival recession (Miller's Class I and II) >2 mm.
  • Identifiable cemento-enamel junction.
  • The tooth with a gingival recession is a vital tooth.
  • Accessible tuberosity.
Show all 10Show fewer
  • Plaque Index and Gingival bleeding index less than 20%.
  • Use an atraumatic dental brushing technique.
  • Provide signed and dated informed consent form.
  • Social health insurance.

Who cannot join

  • The tooth with a gingival recession is a molar
  • Prosthetic crown, restoration or tooth decay involving the CEJ
  • Previous periodontal plastic surgery in the area
  • Smokers up to 10 per day.
  • Patient with untreated periodontal disease.
  • Presence of clinical signs of active periodontal disease
Show all 9Show fewer
  • Known pregnancy in progress
  • Contraindication to surgery
  • Patient deprived of liberty or under legal protection measure.

Trial locations and contacts

No sites are listed yet.

Sébastien MOREAUX, MD contact

+33 6 21 52 34 66

sn.moreaux@gmail.com

About this study

Official title: Tuberosity Versus Palatal Donor Site for Subepithelial Connective Tissue Graft in Root Coverage Therapy: a Randomized Clinical Trial (TOPGRAFT)

Gingival recessions are characterized by the apical migration of the marginal gingivae toward the cemento-enamel junction. Our team in France reported that 84,6% of the population exhibited gingival recession. Other epidemiologic data report that 25% of an american population exhibit recessions deeper than 3mm.

Recessions may be associated with thermic or mecanic related pains and increased wear of the roots. It may causes aesthetic prejudice on smiling. It may also complicate prosthetic reconstruction when the volume of tissue are insufficient. A study on a Brazilian population reported that recessions negatively impacted the quality of life in terms of esthetics and root sensitivity.

Read more

Many surgical procedures have been created to treat these recessions. Most of them include a gingival graft by mean of a sub-epithelial connective tissue graft. Usually it is harvested in the hard palate. However, the early healing of the palate may be associated with important pain and discomfort. Another harvesting site is the retromolar tuberosity. It seems to be of higher tissular quality and lower healing complications. However its limited volume prevent the harvesting of large graft.

Almost no studies have compared the clinical outcome between palatal and tuberosity graft. A retrospective study of our team reported higher rate of complet root coverage with tuberosity graft versus palatal graft (OR=3,78 IC95%). After this observational study, our work introduce a interventional comparison between the two harvesting sites.

Read the detailed description

Recruitment and inclusion:

Patients will be recruited from the consultation of the service of periodontology at Rothschild hospital, Paris, France. All eligible willing participant is included between 2 to 8 weeks before intervention. At that time, data are collected, including periodontal parameters and standardized photographs.

Randomization:

It is performed right before intervention by the operator via CleanWEB. Surgical protocol Both test and control groups will be treated with the same flap design. Patient will receive local anaesthesia at the recession and donor site (articaine hydrochloride 7200 mg/1.8 ml, adrenalin 1800 mcg/1.8 ml).

Envelope technique:

By means of a blade (Bard-Parker 15C; Beckton Dickinson) incision stars in the sulcus of the treated teeth, as tissue thickness permits, sharp dissection is used to form a partial-thickness supraperiosteal envelope extending 3 fo 5 mm internally and apically to areas of recession, undermining intermediate papillae. The supra-periosteal dissection will extend well into the mucosal tissues in order to gain flap mobility. The adjacent papillary tissues will be carefully detached by a full-thickness preparation in their buccal aspect, thus to allow for a coronal displacement of the mobilized buccal soft tissue complex.

In accord with the randomization process, one of the following techniques could be employed.

The donor area in the palate anesthetized by block anesthesia of the grater palatine and nasopalatine nerves with a local anesthetic agent containing epinephrine.

Palate : Single-incision technique In this technique, only a single incision parallel 2mm from the gingival margin is use to access to the donor site for graft harvesting. The angle of the blade is 90 degrees to the bone. After the first incision the blade is angle to approximately 135 degrees, and an undermining preparation toward the median is started within the first incision. With each new movement of the scalpel along the incision line, the angle is further flattened until the blade reaches a nearly parallel position to the bone surface. No vertical incisions are to be made, the goal of this procedure is to create a partial-thickness mucosal flap with a uniform thickness of 1 to 1.5 mm depending in the needs for the recipient site. The underlying CTG is separated from the surrounding connective tissue by making incisions to bone on the mesial, distal sides of the graft. The graft can then be removed by detaching it from the bony surface with a periosteal elevator. Suture of the donor site: crossed and parallel horizontal suspension sutures secure the incision and the donor site.

Tuberosity : Distal wedge technique The procedure starts with two converging incisions perpendicular to the tissue surface and 1.0-1.5 mm deep as far distal to the last molar as possible while remaining within the masticatory mucosa. Then, an undermining partial-thickness incision buccal and palatal up to the mesial surface of the last molar is made. The scalpel is guided successively parallel to the buccal or palatal soft tissue surfaces to yield a partial-thickness flap of uniform thickness throughout. After a supraperiosteal incision is made the wedge-shaped graft is removed from he donor site by sharp dissection. The covering epithelium on the upper part of the graft is consequently removed extraorally. The donor site is closed with an external horizontal mattress suture anchored to the periosteum. Additional single interrupted sutures can be used to completely close the wound.

Graft considerations Care should be taken to avoid graft dehydration from the moment when the graft is taken until the wound from the donor site is closed, so it should be store in a gauze soaked in physiologic saline until further use.

Extra oral modifications in SCTGs is often necessary, a fresh scalpel blade could be used to cut the graft to the desired size and shape and to thin the SCTG as needed, also fat and glandular tissue remnants detected on the graft should be removed.

Graft positioning and suturing The connective tissue graft is place in the created envelope, small parts of the CTG could be left uncovered when necessary to achieve a harmonious line of the gingival margin.

Prior to suturing, the contact points of the affected teeth need to be temporarily splinted with a flowable, light-curing resin material.

Suturing material is a non resorbable suture (Prolène 5.0: Ethicon - Cornelia, Georgia, USA).

Starting at the buccal aspect, the needle is guided through the buccal soft tissue complex approximately 5 mm apical to the tip of the papilla. so the needle will reappear in the base of the palatal papilla area. Consecutively, the needle will be wrapped around the splinted contact region and slid underneath the contact point to re-appear at the palatal side again without pinching any soft tissue. The same procedure is repeated once again, now starting from the palatal aspect.

Thereon the needle will be led over and placed underneath the contact point to re-appear at the buccal aspect again without pinching any soft tissue

Post-surgical protocol Patients have to avoid mechanical trauma or tooth brushing in the surgical sites for two weeks. Chlorhexidine rises are prescribed three times per day for two weeks. Two weeks after the surgery patients are instructed to mechanical tooth cleaning with a soft brush.

Following this, regular tooth brushing habits are resumed and chlorhexidine rinses discontinued.

Standardized photograph are also performed.

Follow up visit Supportive care are provided at 6 and 12 months. Data including periodontal parameters and standardized photographs are collected at the 6 months visit and at the12 months visit by an investigator different from the operator.

This is the last visit of the study. Further supportive care are normally provided at the hospital.

Being tested
Sub-epithelial connective tissue graft harvested from the palatal for root coverage procedure, Sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedure
Keywords
Gingival recession, Root coverage, Periodontal plastic surgery, Subepithelial 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.

  • Sub-epithelial connective tissue graft harvested from the palatal for root coverage procedureProcedure or surgery

    Also called Palatal graft

    Envelope technique + sub-epithelial connective tissue graft harvested from the palatal for root coverage procedure

  • Sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedureProcedure or surgery

    Also called Tuberosity graft

    Envelope technique + sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedure

Study groups in NCT03661619
Study groupRoleWhat they receive
Control GroupExperimentalEnvelope technique + sub-epithelial connective tissue graft harvested from the palatal for root coverage procedure
Receives: Procedure: Sub-epithelial connective tissue graft harvested from the palatal for root coverage procedure
Test GroupExperimentalEnvelope technique + sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedure
Receives: Procedure: Sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedure

What is being measured

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

  1. Gingival recession

    The distance from CEJ to the gingival margin in the mid-buccal site of the treated tooth. Recession will be measured where there is the greatest distance between the marginal gingiva and the cemento-enamel junction (CEJ) in the vertical direction.

    Measured: 12 months

Secondary outcomes (6)
  1. Pocket depth

    on the mesio-, mid-, and disto-buccal sites, the distance from gingival margin to the bottom of the gingival sulcus.

    Measured: 12 months

  2. Keratinized tissue heigth

    The distance between the soft tissue margin and the mucogingival junction at the facial aspect of the tooth.

    Measured: 12 months

  3. Aesthetic evaluation

    A before-after scoring panel system will be used. Each preoperative and postoperative photograph is reframed for matching with a photo editing application and imported in presentation software.

    The views will be rated in one session by an independent professional examiner (periodontist).

    The observer will be masked to the patient, the operator, and the given treatment. The cosmetic results will be scored using the following five-point ordinal improvement scale:

    poor (1), fair (2), good (3), very good (4), and excellent (5).

    The observer will be asked to score for each before/after picture in eight parameters:

    1. -Global esthetic appearance
    2. -Degree of root coverage
    3. -Color match
    4. -Texture match
    5. -Volume match
    6. -Lack of hypertrophic scars
    7. -Existing keratinized tissues
    8. -Gingival contour

    Measured: 12 months

  4. Post operative morbidity assessment

    Each patient will answer a questionnaire. Post operative morbidity will be evaluated at 2 weeks regarding the intensity of the given event and be marked on a 10 points visual analogue scale (VAS).

    Measured: 2 weeks

  5. Aesthetics and satisfaction assessment

    Aesthetics and satisfaction will be evaluated at the 12-months follow-up visit. Patients will be asked to select among 3 items.

    Measured: 12 months

  6. Duration of surgery

    How long in minutes last the intervention.

    Measured: intraoperative

Timeline

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

  1. First posted7 Sep 2018
  2. Study startOct 2018 (estimated)
  3. Primary completionOct 2020 (estimated)
  4. Study completionOct 2020 (estimated)

Resources

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
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03661619
Sponsor's protocol ID
K171206J
Acronym
TOPGRAFT
Status last verified
Jun 2018
First submitted
15 Jun 2018
Last updated
11 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sub-epithelial connective tissue graft harvested from the palatal for root coverage procedure and Sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedure in people with Gingival Recession, run by Assistance Publique - Hôpitaux de Paris.

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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Philippe BOUCHARD, PU-PH (+33 6 14 65 69 47, philippe.bouchard.perio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gingival recession (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 11 Oct 2018; AzTrials last refreshed its copy on 6 Nov 2026.

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