Gingival Recession, LocalizedNCT03417232
Biologically Guided Flap Stability: the Role of Periosteum Retention on the Performance of the Coronally Advanced Flap
A study testing CAF in people with Gingival Recession, Localized, run by University of Siena.
Trial summary
Aim: to evaluate the possible benefit on wound healing and flap stability of periosteum inclusion, comparing a "split-full-split" thickness flap elevation versus a "split" thickness approach performed during CAF for the treatment of isolated-type gingival recessions in the upper jaw. 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, Localized
- What is being tested?
- CAF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2013to 30 Apr 2015
- 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
- age >18 years,
- no systemic diseases or pregnancy,
- smoking ≤10 cigarettes/day,
- full-mouth plaque score and full-mouth bleeding score ≤20%,
- presence of at least one Miller class I or II isolated recession defect (Miller, 1985) in the upper jaw and at least 2 mm of keratinized tissue apical to the recession,
- recession depth (RD) equal to or greater than 2mm,
- identifiable cemento-enamel junction (CEJ),
- vital teeth, free from caries or prosthetic crown,
Who cannot join
- systemic diseases or pregnancy,
- history of periodontal surgery at experimental sites.
About this study
Official title: Biologically Guided Flap Stability: the Role of Periosteum Retention on the Performance of the Coronally Advanced Flap. A Double Blind Randomized Clinical Trial
Aim: to evaluate the possible benefit on wound healing and flap stability of periosteum inclusion, comparing a "split-full-split" thickness flap elevation versus a "split" thickness approach performed during CAF for the treatment of isolated-type gingival recessions in the upper jaw.
Material and Methods: forty patients were randomized, 20 were treated with "split-full-split" (test group) and 20 with a "split" approach (control group). Analyzed parameters at 1 year were: CRC, percentage of Recession Coverage (RC), Keratinized tissue (KT) gain, patient-related outcome measurements.
Read the detailed description
Treatment of buccal gingival recession (GR) is the common clinical requirement from patients who are mainly concerned about aesthetics. Noteworthy are also requests linked to root sensitivity, difficulty in oral hygiene procedures, presence of root caries and non-carious cervical lesions. GR defects, when left untreated, do not improve spontaneously and may progress toward increased recession depth (RD) and clinical attachment loss which increase the patient's aesthetic concern and the clinical discomfort due to augmented dental hypersensitivity.
Complete root coverage (CRC) can be considered the primary clinical outcome and selecting the surgical technique depends mainly on the local anatomical characteristics and on the patient's demands.
In patients with a residual amount of keratinized tissue apical to the recession defect, the coronal advanced flap (CAF) may be recommended. This surgical technique results in optimal root coverage, good color blending of the treated area with respect to adjacent soft tissues and a complete recovery of the original (pre-surgical) soft tissue marginal morphology. Furthermore, post-operative morbidity is reduced to a single area of surgical intervention and the overall chair time is limited.
When utilizing CAF technique, critical factors in CRC have been described in the literature. Flap positioning coronal to the CEJ and a tension-free flap design are among the most important ones. Moreover, flap thickness has been shown to influence the clinical outcomes of CAF procedure .
Coronally advanced flap has been widely validated by the literature for the treatment of single recession defects and, currently, different flap designs and technical modifications are available to clinicians.
De Sanctis and Zucchelli have recently introduced the "split-full-split" flap elevation modality. According to the authors, the modulation of flap thickness, produced by the inclusion of periosteum in the central area, increases flap thickness in the portion of the flap residing over the previously exposed avascular root surface. This, in turn, would give better stability to the flap. However, the partial-thickness flap approach is still commonly performed in the clinical practice and it is validated in the literature.
To date, evidence is still lacking on the influence of including the periosteum in the flap when compared with a split thickness approach in obtaining a CRC.
Thus, the aim of this double blind, controlled and randomized clinical trial was to evaluate the possible benefit on wound healing and flap stability of periosteum inclusion comparing a "split-full-split" flap elevation versus a "split" thickness approach when CAF is performed for the treatment of isolated-type gingival recessions in the upper jaw.
- Conditions
- Gingival Recession, Localized
- Being tested
- CAF
- Keywords
- gingival recession, coronally advanced flap, complete root coverage, flap elevation, flap thickness
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAFProcedure or surgery
The design of the flap consisted of two horizontal beveled incisions (3mm in length) and two slightly oblique beveled incisions. The resulting trapezoidal-shaped flap was elevated in the coronal-apical direction. The suture of the flap started with two interrupted periosteal sutures performed at the most apical extension of the vertical releasing incisions; afterwards, it proceeded coronally with other interrupted sutures, each of them directed, from the flap to the adjacent buccal soft tissue, in the apical-coronal direction. The last sling suture allowed for the stabilization of the surgical papillae over the inter-dental connective tissue bed and allowed for a precise adaptation of the flap margin over the underlying convexity of the crown.
| Study group | Role | What they receive |
|---|---|---|
| Split Full Split Elevation of CAF | Experimental | The central portion of the flap apical to the recession was elevated full thickness by the use of a small periostium elevator inserted into the probable sulcus Receives: Procedure: CAF |
| Split Elevation of CAF | Sham comparator | The flap was fully elevated with a split thickness approach: the blade of the knife was inserted into the sulcus Receives: Procedure: CAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRC
Percentages of recession with a Complete Root Coverage
Measured: 12 months
Secondary outcomes (5)
RC
percentages of Recession Coverage
Measured: 12 months
KTH
Keratinized Tissue Height in mm.
Measured: 12 months
VAS discomfort
patient's discomfort expressed in a 10 cm Visual Analogue Scale, indicating discomfort from 0 (no discomfort) to 10 (maximum discomfort)
Measured: 12 months
VAS esthetic
patient's esthetic expressed in a 10 cm Visual Analogue Scale, indicating esthetic from 0 (worst esthetic) to 10 (optimum esthetic).
Measured: 12 months
VAS satisfaction
patient's satisfaction expressed in a 10 cm. Visual Analogue Scale, indicating satisfaction from 0 (no satisfaction) to 10 (good satisfaction).
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 posted31 Jan 2018
- Study start1 Apr 2013
- Primary completion30 Apr 2015
- Study completion30 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, LocalizedStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Marco Ferrari, University of Siena
- Investigators
- Massimo De Sanctis, MD, Principal investigator, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417232
- Sponsor's protocol ID
- CAF0001
- Status last verified
- Jan 2018
- First submitted
- 23 Jan 2018
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Clementini M, Discepoli N, Danesi C, de Sanctis M. Biologically guided flap stability: the role of flap thickness including periosteum retention on the performance of the coronally advanced flap-A double-blind randomized clinical trial. J Clin Periodontol. 2018 Oct;45(10):1238-1246. doi: 10.1111/jcpe.12998. Epub 2018 Sep 14.
PubMed 30099762
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologically Guided Flap Stability: the Role of Periosteum Retention on the Performance of the Coronally Advanced Flap. A Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03417232
- Acronym / sponsor ID
- CAF0001
- Conditions
- Gingival Recession, Localized
- Keywords
- gingival recession, coronally advanced flap, complete root coverage, flap elevation, flap thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 30 Apr 2015 (actual)
- Study completion
- 30 Apr 2015 (actual)
- First posted
- 31 Jan 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.
Aim: to evaluate the possible benefit on wound healing and flap stability of periosteum inclusion, comparing a "split-full-split" thickness flap elevation versus a "split" thickness approach performed during CAF for the treatment of isolated-type gingival recessions in the upper jaw.
Material and Methods: forty patients were randomized, 20 were treated with "split-full-split" (test group) and 20 with a "split" approach (control group). Analyzed parameters at 1 year were: CRC, percentage of Recession Coverage (RC), Keratinized tissue (KT) gain, patient-related outcome measurements.
Detailed description
Treatment of buccal gingival recession (GR) is the common clinical requirement from patients who are mainly concerned about aesthetics. Noteworthy are also requests linked to root sensitivity, difficulty in oral hygiene procedures, presence of root caries and non-carious cervical lesions. GR defects, when left untreated, do not improve spontaneously and may progress toward increased recession depth (RD) and clinical attachment loss which increase the patient's aesthetic concern and the clinical discomfort due to augmented dental hypersensitivity.
Complete root coverage (CRC) can be considered the primary clinical outcome and selecting the surgical technique depends mainly on the local anatomical characteristics and on the patient's demands.
In patients with a residual amount of keratinized tissue apical to the recession defect, the coronal advanced flap (CAF) may be recommended. This surgical technique results in optimal root coverage, good color blending of the treated area with respect to adjacent soft tissues and a complete recovery of the original (pre-surgical) soft tissue marginal morphology. Furthermore, post-operative morbidity is reduced to a single area of surgical intervention and the overall chair time is limited.
When utilizing CAF technique, critical factors in CRC have been described in the literature. Flap positioning coronal to the CEJ and a tension-free flap design are among the most important ones. Moreover, flap thickness has been shown to influence the clinical outcomes of CAF procedure .
Coronally advanced flap has been widely validated by the literature for the treatment of single recession defects and, currently, different flap designs and technical modifications are available to clinicians.
De Sanctis and Zucchelli have recently introduced the "split-full-split" flap elevation modality. According to the authors, the modulation of flap thickness, produced by the inclusion of periosteum in the central area, increases flap thickness in the portion of the flap residing over the previously exposed avascular root surface. This, in turn, would give better stability to the flap. However, the partial-thickness flap approach is still commonly performed in the clinical practice and it is validated in the literature.
To date, evidence is still lacking on the influence of including the periosteum in the flap when compared with a split thickness approach in obtaining a CRC.
Thus, the aim of this double blind, controlled and randomized clinical trial was to evaluate the possible benefit on wound healing and flap stability of periosteum inclusion comparing a "split-full-split" flap elevation versus a "split" thickness approach when CAF is performed for the treatment of isolated-type gingival recessions in the upper jaw.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Split Full Split Elevation of CAF | Experimental | Procedure: CAFThe central portion of the flap apical to the recession was elevated full thickness by the use of a small periostium elevator inserted into the probable sulcus |
| Split Elevation of CAF | Sham comparator | Procedure: CAFThe flap was fully elevated with a split thickness approach: the blade of the knife was inserted into the sulcus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age >18 years,
- no systemic diseases or pregnancy,
- smoking ≤10 cigarettes/day,
- full-mouth plaque score and full-mouth bleeding score ≤20%,
- presence of at least one Miller class I or II isolated recession defect (Miller, 1985) in the upper jaw and at least 2 mm of keratinized tissue apical to the recession,
Key exclusion criteria (2 listed)
- systemic diseases or pregnancy,
- history of periodontal surgery at experimental sites.
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 |
|---|---|---|
| CAFThe design of the flap consisted of two horizontal beveled incisions (3mm in length) and two slightly oblique beveled incisions. The resulting trapezoidal-shaped flap was elevated in the coronal-apical direction. The suture of the flap started with two interrupted periosteal sutures performed at the most apical extension of the vertical releasing incisions; afterwards, it proceeded coronally with other interrupted sutures, each of them directed, from the flap to the adjacent buccal soft tissue, in the apical-coronal direction. The last sling suture allowed for the stabilization of the surgical papillae over the inter-dental connective tissue bed and allowed for a precise adaptation of the flap margin over the underlying convexity of the crown. | Procedure or surgery | Split Elevation of CAF, Split Full Split Elevation of CAF |
Primary outcome
CRC
Time frame: 12 months
Percentages of recession with a Complete Root Coverage
5 secondary outcomes
RC
Time frame: 12 months
KTH
Time frame: 12 months
VAS discomfort
Time frame: 12 months
VAS esthetic
Time frame: 12 months
VAS satisfaction
Time frame: 12 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 1 Feb 2018.
- Derived from this study: PubMed 30099762Clementini M, Discepoli N, Danesi C, de Sanctis M. Biologically guided flap stability: the role of flap thickness including periosteum retention on the performance of the coronally advanced flap-A double-blind randomized clinical trial. J Clin Periodontol. 2018 Oct;45(10):1238-1246. doi: 10.1111/jcpe.12998. Epub 2018 Sep 14.
- Individual participant dataSharing planned: Undecided
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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.
Massimo De Sanctis, MD principal investigator
University of Siena
Questions about this trial
What is this clinical trial studying?
A study testing CAF in people with Gingival Recession, Localized, run by University of Siena.
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 8 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: finished, as of the sponsor's last update on 1 Feb 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. Some participants in this study may receive a placebo. 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?
CRC (time frame: 12 months). 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 NCT03417232, which also lists 1 linked publication.
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 1 Feb 2018.