Gingival RecessionNCT04813302
Influence of Anatomical Factors Upon Root Coverage
A study testing Coronally advanced flap and connective tissue graft in people with Gingival Recession and Gingival Diseases, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
Introduction: Gingival recession is a lesion characterized by the loss of attachment of root surface of the tooth, resulting in an apical migration of the gingival margin that occasionally generates aesthetic problems, hypersensitivity and difficulty in maintaining proper hygiene. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Gingival Diseases, Periodontal Attachment Loss
- What is being tested?
- Coronally advanced flap and connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2019to 15 Mar 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years.
- Periodontally and systemically healthy.
- Presence of Miller class I and II GR defects or class III with no interproximal clinical attachment loss.
- Recession >2mm in depth at the buccal aspect.
- Full-mouth plaque and bleeding score ≤20%.
- No previous periodontal surgery.
- Presence of identifiable CEJ (a step ≤1mm at the CEJ and/or presence of root abrasion, but with identifiable CEJ, will be accepted).
Who cannot join
- Tobacco smoking of ≥10 cigarettes a day.
- Contraindications for periodontal surgery.
- Medications known to affect the gingiva or interfere with wound healing.
- Pregnancy.
- Active orthodontic therapy.
- caries or restorations in the area to be treated.
Trial locations and contacts
1 site in 1 country.
About this study
Introduction:
Gingival recession is a lesion characterized by the loss of attachment of root surface of the tooth, resulting in an apical migration of the gingival margin that occasionally generates aesthetic problems, hypersensitivity and difficulty in maintaining proper hygiene.
Read more
Several anatomical factors have been associated both with the incidence and progression of gingival recession and with the prognosis of the surgical treatments proposed for its correction. These factors include the absence of keratinized tissue, the gingival phenotype, root prominence and shallow vesrtibular depth.
Objectives:
The objective of the study is to evaluate, through a series of prospective cases, the influence of each of the anatomical factors on the success of root coverage.
Methods:
20 patients with gingival recession defects will be treated with CAF+CTG using various autogenous gingival graft. Three-dimensional analysis of superimposed preoperative and postoperative images will be performed. Linear and surface root coverage will be calculated and correlated to various anatomical parameters such as vestibular depth and root prominence. A multilevel statistical analysis will be conducted, adjusting for the correlation among multiple observations.
Read the detailed description
- Pre-surgical treatment: Initial periodontal therapy will be performed 1 month prior to surgery. Patients will receive a pre-surgical prophylaxis, oral hygiene instructions and elimination of toothbrushing traumatic technique, if needed. They will be taught to use a toothbrush of medium hardness applying Roll brushing technique.
- Surgical treatment: In brief description, CAF+CTG treatment will be performed by starting with two vertical releasing incisions lateral to the teeth to be treated and split-full-split thickness flap will be raised beyond the MGJ. The periosteum will be cut, and a blunt dissection into the vestibular lining mucosa will be carried out to eliminate muscle tension so that the mucosal flap can be passively positioned above the level of CEJ on the tooth. The papillae adjacent to the involved teeth will be de-epithelialized and the exposed root surfaces will be treated with pre-conditioning EDTA (Straumann PrefGel®) for 2 minutes. CTG of 1mm in thickness will be harvested from the posterior palate by means of disepithelization of a free gingival graft (22), cut to the exact size of the defect, and placed over the dehisced defect, sutured to the interdental papillae (7-0 Polyglactin 910, Vycril, Ethicon, Johnson and Johnson, New Brunswick, NJ, USA) and subsequently covered with CAF. Sling sutures will be placed to stabilize the flap in a coronal position about 1-2 mm above the CEJ (6-0 Polypropylene, Prolene, Ethicon, Johnson and Johnson, New Brunswick, NJ, USA), followed by interrupted sutures to close the releasing incisions.
Patients will be instructed to avoid any mechanical trauma or tooth brushing in the surgical sites for 2 weeks. Analgesic medication (ibuprofen) will be prescribed as required and patients will be instructed to rinse with Chlorhexidine three times per day for 2 weeks. Sutures will be removed after 14 days. Two weeks after surgery, patients will resume mechanical tooth cleaning with a soft toothbrush. Patients will be recalled at 1, 3 and 6 months for professional oral hygiene procedures.
- Post-surgical instructions and infection control: Patients will be instructed to avoid any mechanical trauma or tooth brushing in the surgical sites for 2 weeks. Analgesic medication (ibuprofen) will be prescribed as required and patients will be instructed to rinse with Chlorhexidine 0.12% two times per day for 2 weeks. Sutures will be removed after 14 days. Two weeks after surgery, patients will resume mechanical tooth cleaning with a soft toothbrush. Patients will be recalled at 1, 3 and 6 months for professional oral hygiene procedures.
- Data collection: A guidebook will be prepared to systematize the procedures for sample and data collection. The data will be later transferred to a computerized database (Epidata®, Odense, Denmark, Europe).
- Sociodemographic data An interview will be conducted during the pre-surgical visit to obtain information regar- ding age, sex, medical history, use of medication, exposure to tobacco, pregnancy and previous periodontal surgeries.
- Clinical measurements Probing depth (PD) and keratinized tissue width (KTW) will be measured using a periodontal probe (PCP UNC 15, Hu-Friedy, Chicago, IL, USA). KTW will be measured at the most apical point in the GM to the mucogingival junction at the mid-buccal site to the nearest millimeter. KTT will be measured 1.5mm and 3mm apical to the GM using an injection needle, perpendicular to the tissues surface and a silicon stop over the gingival surface and fixed with a cyanoacrylic adhesive (23). Clinical attachment level will be calculated as REC + PD.
- Digital measurements All patients will be scanned and their models will be digitalized with an optical 3D measurement system (3Shape, Erlangen, Germany) creating surface tessellation language (STL) files while a bilateral retractor is placed in the mouth and teeth are held lightly in occlusion. The acquired data will be transferred into a digital imaging software (3Shape Trios®, Erlangen, Germany) in which patient name will be substituted for a random ID number in order to anonymize the data. Baseline and corresponding follow-up scans of each clinical case will be then virtually superimposed and matched into one common coordinate system (Geomagic, 3D Systems, Research Triangle Park, NC, USA) using the tool Control X. By using the buccal surfaces of the concerned teeth as reference points for the superpositioning of the different time points (pre-operative and post-operative), this approach will allow for precise evaluation of dimensional soft tissue alterations over time by a blinded examiner. Vestibular depth will be measured from the GM to the point of greatest concavity of the mucobuccal fold.
The digital linear and volumetric measurements and assessment will be performed by a single, calibrated examiner for the surgical. The examiner will be trained on 15 casts with gingival recessions who will not be included in this study. This examination will be repeated 24 h later; differences of ≤0.5 mm in at least 90% of the cases will be considered to be acceptable.
The following measurements will be taken:
All clinical measurements and volumetric evaluations of the soft will be performed at baseline, 3 months and at 6 months after surgery.
- Being tested
- Coronally advanced flap and connective tissue graft
- Medical subject headings
- Gingival Recession, Gingival Diseases, Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronally advanced flap and connective tissue graftProcedure or surgery
CAF+CTG treatment will be performed by starting with two vertical releasing incisions lateral to the teeth to be treated and split-full-split thickness flap will be raised beyond the MGJ. The periosteum will be cut, and a blunt dissection into the vestibular lining mucosa will be carried out to eliminate muscle tension so that the mucosal flap can be passively positioned above the level of CEJ on the tooth. The papillae adjacent to the involved teeth will be de-epithelialized. CTG of 1mm in thickness will be harvested from the posterior palate by means of disepithelization of a free gingival graft, cut to the exact size of the defect, and placed over the dehisced defect, sutured to the interdental papillae and subsequently covered with CAF. Sling sutures will be placed to stabilize the flap in a coronal position about 1-2 mm above the CEJ , followed by interrupted sutures to close the releasing incisions.
| Study group | Role | What they receive |
|---|---|---|
| Gingival recession treatment | Experimental | Gingival recession treatment by means of a coronally advanced flap and a connective tissue graft Receives: Procedure: Coronally advanced flap and connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Root Coverage
By using the buccal surfaces of the concerned teeth as reference points for the superimposition of the different time points (pre-operative and post-operative), this approach will allow for the precise evaluation of dimensional soft tissue alterations over time.
Measured: 6 months
Secondary outcomes (1)
Mean Root Coverage
By using the buccal surfaces of the concerned teeth as reference points for the superimposition of the different time points (pre-operative and post-operative), this approach will allow for the precise evaluation of dimensional soft tissue alterations over time.
Measured: 6 months
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 start15 Sep 2019
- Primary completion15 Dec 2020
- Study completion15 Mar 2021
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonzalo Blasi, Universitat Internacional de Catalunya
- Investigators
- Jose Nart, DDS PhD, Study chair, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813302
- Sponsor's protocol ID
- PER-ECL-2019-04
- Status last verified
- Mar 2021
- First submitted
- 21 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Influence of Anatomical Factors Upon Root Coverage
- ClinicalTrials.gov ID
- NCT04813302
- Acronym / sponsor ID
- PER-ECL-2019-04
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Mar 2021 (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.
Introduction:
Gingival recession is a lesion characterized by the loss of attachment of root surface of the tooth, resulting in an apical migration of the gingival margin that occasionally generates aesthetic problems, hypersensitivity and difficulty in maintaining proper hygiene.
Several anatomical factors have been associated both with the incidence and progression of gingival recession and with the prognosis of the surgical treatments proposed for its correction. These factors include the absence of keratinized tissue, the gingival phenotype, root prominence and shallow vesrtibular depth.
Objectives:
The objective of the study is to evaluate, through a series of prospective cases, the influence of each of the anatomical factors on the success of root coverage.
Methods:
20 patients with gingival recession defects will be treated with CAF+CTG using various autogenous gingival graft. Three-dimensional analysis of superimposed preoperative and postoperative images will be performed. Linear and surface root coverage will be calculated and correlated to various anatomical parameters such as vestibular depth and root prominence. A multilevel statistical analysis will be conducted, adjusting for the correlation among multiple observations.
Detailed description
- Pre-surgical treatment: Initial periodontal therapy will be performed 1 month prior to surgery. Patients will receive a pre-surgical prophylaxis, oral hygiene instructions and elimination of toothbrushing traumatic technique, if needed. They will be taught to use a toothbrush of medium hardness applying Roll brushing technique.
- Surgical treatment: In brief description, CAF+CTG treatment will be performed by starting with two vertical releasing incisions lateral to the teeth to be treated and split-full-split thickness flap will be raised beyond the MGJ. The periosteum will be cut, and a blunt dissection into the vestibular lining mucosa will be carried out to eliminate muscle tension so that the mucosal flap can be passively positioned above the level of CEJ on the tooth. The papillae adjacent to the involved teeth will be de-epithelialized and the exposed root surfaces will be treated with pre-conditioning EDTA (Straumann PrefGel®) for 2 minutes. CTG of 1mm in thickness will be harvested from the posterior palate by means of disepithelization of a free gingival graft (22), cut to the exact size of the defect, and placed over the dehisced defect, sutured to the interdental papillae (7-0 Polyglactin 910, Vycril, Ethicon, Johnson and Johnson, New Brunswick, NJ, USA) and subsequently covered with CAF. Sling sutures will be placed to stabilize the flap in a coronal position about 1-2 mm above the CEJ (6-0 Polypropylene, Prolene, Ethicon, Johnson and Johnson, New Brunswick, NJ, USA), followed by interrupted sutures to close the releasing incisions.
Patients will be instructed to avoid any mechanical trauma or tooth brushing in the surgical sites for 2 weeks. Analgesic medication (ibuprofen) will be prescribed as required and patients will be instructed to rinse with Chlorhexidine three times per day for 2 weeks. Sutures will be removed after 14 days. Two weeks after surgery, patients will resume mechanical tooth cleaning with a soft toothbrush. Patients will be recalled at 1, 3 and 6 months for professional oral hygiene procedures.
- Post-surgical instructions and infection control: Patients will be instructed to avoid any mechanical trauma or tooth brushing in the surgical sites for 2 weeks. Analgesic medication (ibuprofen) will be prescribed as required and patients will be instructed to rinse with Chlorhexidine 0.12% two times per day for 2 weeks. Sutures will be removed after 14 days. Two weeks after surgery, patients will resume mechanical tooth cleaning with a soft toothbrush. Patients will be recalled at 1, 3 and 6 months for professional oral hygiene procedures.
- Data collection: A guidebook will be prepared to systematize the procedures for sample and data collection. The data will be later transferred to a computerized database (Epidata®, Odense, Denmark, Europe).
- Sociodemographic data An interview will be conducted during the pre-surgical visit to obtain information regar- ding age, sex, medical history, use of medication, exposure to tobacco, pregnancy and previous periodontal surgeries.
- Clinical measurements Probing depth (PD) and keratinized tissue width (KTW) will be measured using a periodontal probe (PCP UNC 15, Hu-Friedy, Chicago, IL, USA). KTW will be measured at the most apical point in the GM to the mucogingival junction at the mid-buccal site to the nearest millimeter. KTT will be measured 1.5mm and 3mm apical to the GM using an injection needle, perpendicular to the tissues surface and a silicon stop over the gingival surface and fixed with a cyanoacrylic adhesive (23). Clinical attachment level will be calculated as REC + PD.
- Digital measurements All patients will be scanned and their models will be digitalized with an optical 3D measurement system (3Shape, Erlangen, Germany) creating surface tessellation language (STL) files while a bilateral retractor is placed in the mouth and teeth are held lightly in occlusion. The acquired data will be transferred into a digital imaging software (3Shape Trios®, Erlangen, Germany) in which patient name will be substituted for a random ID number in order to anonymize the data. Baseline and corresponding follow-up scans of each clinical case will be then virtually superimposed and matched into one common coordinate system (Geomagic, 3D Systems, Research Triangle Park, NC, USA) using the tool Control X. By using the buccal surfaces of the concerned teeth as reference points for the superpositioning of the different time points (pre-operative and post-operative), this approach will allow for precise evaluation of dimensional soft tissue alterations over time by a blinded examiner. Vestibular depth will be measured from the GM to the point of greatest concavity of the mucobuccal fold.
The digital linear and volumetric measurements and assessment will be performed by a single, calibrated examiner for the surgical. The examiner will be trained on 15 casts with gingival recessions who will not be included in this study. This examination will be repeated 24 h later; differences of ≤0.5 mm in at least 90% of the cases will be considered to be acceptable.
The following measurements will be taken:
All clinical measurements and volumetric evaluations of the soft will be performed at baseline, 3 months and at 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gingival recession treatment | Experimental | Procedure: Coronally advanced flap and connective tissue graftGingival recession treatment by means of a coronally advanced flap and a connective tissue graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years.
- Periodontally and systemically healthy.
- Presence of Miller class I and II GR defects or class III with no interproximal clinical attachment loss.
- Recession >2mm in depth at the buccal aspect.
- Full-mouth plaque and bleeding score ≤20%.
Key exclusion criteria (6 listed)
- Tobacco smoking of ≥10 cigarettes a day.
- Contraindications for periodontal surgery.
- Medications known to affect the gingiva or interfere with wound healing.
- Pregnancy.
- Active orthodontic therapy.
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 |
|---|---|---|
| Coronally advanced flap and connective tissue graftCAF+CTG treatment will be performed by starting with two vertical releasing incisions lateral to the teeth to be treated and split-full-split thickness flap will be raised beyond the MGJ. The periosteum will be cut, and a blunt dissection into the vestibular lining mucosa will be carried out to eliminate muscle tension so that the mucosal flap can be passively positioned above the level of CEJ on the tooth. The papillae adjacent to the involved teeth will be de-epithelialized. CTG of 1mm in thickness will be harvested from the posterior palate by means of disepithelization of a free gingival graft, cut to the exact size of the defect, and placed over the dehisced defect, sutured to the interdental papillae and subsequently covered with CAF. Sling sutures will be placed to stabilize the flap in a coronal position about 1-2 mm above the CEJ , followed by interrupted sutures to close the releasing incisions. | Procedure or surgery | Gingival recession treatment |
Primary outcome
Complete Root Coverage
Time frame: 6 months
By using the buccal surfaces of the concerned teeth as reference points for the superimposition of the different time points (pre-operative and post-operative), this approach will allow for the precise evaluation of dimensional soft tissue alterations over time.
1 secondary outcome
Mean Root Coverage
Time frame: 6 months
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.
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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.
Jose Nart, DDS PhD study chair
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronally advanced flap and connective tissue graft in people with Gingival Recession and Gingival Diseases, run by Universitat Internacional de Catalunya 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 7 inclusion and 6 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 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?
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?
Complete Root Coverage (time frame: 6 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 24 Mar 2021.