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.
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.
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.
- Conditions
- Gingival Recession
- 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 group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Envelope 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 Group | Experimental | Envelope 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.
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)
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
Keratinized tissue heigth
The distance between the soft tissue margin and the mucogingival junction at the facial aspect of the tooth.
Measured: 12 months
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:
- -Global esthetic appearance
- -Degree of root coverage
- -Color match
- -Texture match
- -Volume match
- -Lack of hypertrophic scars
- -Existing keratinized tissues
- -Gingival contour
Measured: 12 months
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
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
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.
- First posted7 Sep 2018
- Study startOct 2018 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe BOUCHARD, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tuberosity Versus Palatal Donor Site for Subepithelial Connective Tissue Graft in Root Coverage Therapy: a Randomized Clinical Trial (TOPGRAFT)
- ClinicalTrials.gov ID
- NCT03661619
- Acronym / sponsor ID
- TOPGRAFT / K171206J
- Conditions
- Gingival Recession
- Keywords
- Gingival recession, Root coverage, Periodontal plastic surgery, Subepithelial connective tissue graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 7 Sep 2018 (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.
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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Procedure: Sub-epithelial connective tissue graft harvested from the palatal for root coverage procedureEnvelope technique + sub-epithelial connective tissue graft harvested from the palatal for root coverage procedure |
| Test Group | Experimental | Procedure: Sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedureEnvelope technique + sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Sub-epithelial connective tissue graft harvested from the palatal for root coverage procedureAlso: Palatal graftEnvelope technique + sub-epithelial connective tissue graft harvested from the palatal for root coverage procedure | Procedure or surgery | Control Group |
| Sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedureAlso: Tuberosity graftEnvelope technique + sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedure | Procedure or surgery | Test Group |
Primary outcome
Gingival recession
Time frame: 12 months
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.
6 secondary outcomes
Pocket depth
Time frame: 12 months
Keratinized tissue heigth
Time frame: 12 months
Aesthetic evaluation
Time frame: 12 months
Post operative morbidity assessment
Time frame: 2 weeks
Aesthetics and satisfaction assessment
Time frame: 12 months
Duration of surgery
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Gingival Recession
Recruiting
i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Gingival Graft, Recession, Gingival
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
Recruiting
Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
Gingival Recession, Mucogingival Surgery
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.
Philippe BOUCHARD, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
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.