Gingival RecessionNCT05439382
Analysis of Root Coverage Stability.
An observational study of Gingival Recession and Surgery, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial summary
One-hundred and one healthy participants (221 gingival recessions-GRs) were treated from 1987 to 1996. The probing depth (PD), keratinized tissue width (KTW), gingival recession depth (RD), gingival recession width (RW), gingival recession area (RA) were evaluated and considered at baseline and along time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession, Surgery, Oral Disease
- What is being tested?
- Gingival recession regenerative surgery
- Type of treatment
- Surgery or procedure
- How many people
- 101 participants
- Where
- 1 siteItaly
- Study dates
- Jan 1987to Dec 2025
- Phase
- Observational
- 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
Study population: Participants screened for the presence of at least one tooth presenting with gingival recession requiring subepithelial tissue graft (bilaminar technique), examined and treated from 1987 at the Periodontology Unit of Dentistry and Oral-Maxillofacial Surgery of Modena University Hospital.
Who may be able to join
- Absence of relevant medical conditions: Medical history of good health. Good oral hygiene: full-mouth plaque score (FMPS) ≤20%. Low level of residual infection: full-mouth bleeding score (FMBS) ≤20%. Participants showing good levels of compliance were selected. Presence of at least one tooth presenting with gingival recession (GR) requiring subepithelial tissue graft, and with identifiable cement-enamel junction (CEJ).
- GR exhibiting an identifiable cemento-enamel junction, and absence of plaque or bleeding on probing (BoP) in the sites scheduled for the procedure.
- GR defects Miller Class I or II without furcation involvement.
Who cannot join
- Pregnant or lactating. Smokers and participants with history of alcohol abuse. Periodontal disease.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Periodontology Unit of Dentistry and Oral-Maxillofacial Surgery of the Modena University Hospital
Modena, 41124
About this study
Official title: Very Long-term Analysis of Root Coverage Stability Using Subepithelial Connective Tissue Graft Techniques for Gingival Recession Treatment.
One-hundred and one healthy participants (221 gingival recessions-GRs) were treated from 1987 to 1996. The probing depth (PD), keratinized tissue width (KTW), gingival recession depth (RD), gingival recession width (RW), gingival recession area (RA) were evaluated and considered at baseline and along time. The obtained data will be evaluated and compared.
Read the detailed description
Dental-periodontal procedures and clinical measurements.
Dental and periodontal conditions were assessed and treated according to needs in all participants. Emergencies, such as pain or acute dental-periodontal infections, were treated to establish a stable dental-periodontal condition. Cause-related therapy, including patient motivation and professional oral hygiene, was planned and completed.
At the end of cause-related therapy, the following baseline clinical measurements were taken by an investigator: probing depth (PD), keratinized tissue width (KTW), full-mouth plaque scores (FMPS), full-mouth bleeding scores (FMBS), bleeding on probing (BoP), gingival recession depth (RD), gingival recession width (RW), and gingival recession area (RA).
PD and KTW were evaluated using a periodontal probe (University of North Carolina Probe 15 tip) to the nearest 0.5mm. PD was measured at 4 aspects per tooth axially, from the free gingival margin to the most apical part of the sulcus, and, additionally, PD at the mid buccal point; KTW at the mid-buccal point, from the free gingival margin to the mucogingival-junction (MGJ). FMPS was recorded as the percentage of total tooth surfaces (4 aspects per tooth) displaying the presence of plaque, FMBS was calculated as the percentage of total tooth surfaces (4 aspects per tooth) showing bleeding on probing (BoP) was dichotomously assessed.
The bi-dimensional shape of each exposed root surface was reproduced with a lead sheet template. The template had the shape of a triangle with a curved base lining the cemento-enamel-junction (CEJ) and two sides lining the mesial and distal margins of the GR merging at the most apical point of the GR. All templates were measured, coded and stored. The following measurements were recently repeated using an image analysis software: RD, from the most apical point of the triangle to the base; RW, measured at the CEJ level (i.e., at the base of the template) and RA, as the total template area.
These measurements were performed from baseline (before surgery).
Surgery.
All surgical procedures were performed by the same trained operator under local anesthesia.
The recipient site started with an intrasulcular incision on the buccal aspect of the involved teeth. The incision was mesio-distally extended to dissect the buccal aspect of the adjacent papillae. Two oblique releasing incisions were performed from the mesial and distal sides of the horizontal incisions beyond MGJ. A full thickness trapezoid flap, next the dental roots, was raised. Partial dissection was made next the papillae and, apically, at the interproximal places.
After the initial preparation of the recipient site and flap, the bilaminar technique required the withdrawal of palatal connective graft. At the palatal donor site, a horizontal incision was made about 3 mm apical to the free gingival margin. For the epithelial connective tissue graft (ECTG), a second incision was made undermining and splitting the palatal flap. Vertical incisions were carried out mesially and distally joining them to the horizontal incision and performing the palatal flap. Another horizontal incision was made apically on the connective tissue to sever the graft tissue. The graft tissue, 1-1.5 mm thick, was placed in the recipient site to cover the exposed dental roots as far as the CEJ, enlarging mesially and distally on the preserved connective and periosteum of the interproximal sites. Absorbable interrupted and compressive subperiosteal sutures were performed to give stability to the graft. Then, if need to ensure flap mobilization and passivity, a partial thickness dissection was made beyond the MGJ, leaving the underlying periosteum in place and release also the muscle tension, allowing the passive mobilization of the flap that had to cover completely the connective tissue graft (CTG) and the dental roots over the CEJ at least of 2mm. The partial thickness dissection was performed immediately before the graft positioning and suture to avoid flap suffering. The pedicle flap was sutured without residual tension. Each of these surgical techniques could be advantageously used both in cases of single or multiple gingival recessions (GRs).
After surgery, patients were instructed to discontinue toothbrushing of the treated area for 7-10 days. Patients were reinforced to use the roll technique, by soft-bristle toothbrushing outside the treated area during the first month after surgery. Interdental brushes and dental floss in the treated area were forbidden for 1-month. Flap sutures were removed after 7-10 days, and therefore the same toothbrushing prescriptions performed after surgery for outside areas were introduced also in the treated areas. Chlorhexidine rinses were prescribed twice a day for 1 min. About 1-month after surgery, all patients were instructed to resume mechanical tooth cleaning. Patients were recalled for professional supportive care in accordance with Italian health rules and regulations on public dentistry (Essential·Level·of·Assistance - LEA), Law no.·419-30·November·1998, regulating the public dentistry) every 6-24 months whenever possible, and ever in case of need. Patients were recalled for clinical re-evaluations.
- Conditions
- Gingival Recession, Surgery, Oral Disease
- Being tested
- Gingival recession regenerative surgery
- Keywords
- Gingival recession, Root coverage, Subepithelial tissue graft
- Medical subject headings
- Gingival Recession, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival recession regenerative surgeryProcedure or surgery
Bilaminar technique was performed by the same trained operator, opening a primary flap in correspondence of the recession site. Tissue was harvested from palatal donor site and grafted beneath the primary flap
| Study group | Role | What they receive |
|---|---|---|
| Langer & Langer technique | Participants undergoing Langer \& Langer surgical technique Receives: Procedure: Gingival recession regenerative surgery | |
| Nelson' modified technique | Participants undergoing Nelson' modified surgical technique Receives: Procedure: Gingival recession regenerative surgery | |
| Coronally advanced flap and subepithelial graft | Participants undergoing Coronally advanced flap and subepithelial graft surgical technique Receives: Procedure: Gingival recession regenerative surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal pocket probing depth (PD)
Measurements of the periodontal pocket depth in millimeters
Measured: From surgery to December 2023
Keratinized tissue width (KTW)
Measurements of the width of keratinized tissue (gingiva), in millimeters, from the free gingival margin to the mucogingival junction
Measured: From surgery to December 2023
Gingival recession depth (RD)
Measurements of the depth of the gingival recession, in millimeters, from the cementoenamel junction to the most apical part of the gingival recession
Measured: From surgery to December 2023
Gingival recession width (RW)
Measurements of the width of the gingival recession, in millimeters, from the mesial to distal part of the uncovered cementoenamel junction
Measured: From surgery to December 2023
Gingival recession area (RA)
Measurements of the area, in square millimeters, of the gingival recession
Measured: From surgery to December 2023
Secondary outcomes (5)
Correlation between initial and late measurements of probing depth (PD)
Evaluation of mutual correlation of probing depth (PD) with all the measured indices listed as primary outcome
Measured: From surgery to December 2023
Correlation between initial and late measurements of keratinized tissue width (KTW)
Evaluation of mutual correlation of keratinized tissue width (KTW) with all the measured indices listed as primary outcome
Measured: From surgery to December 2023
Correlation between initial and late measurements of gingival recession depth (RD)
Evaluation of mutual correlation of gingival recession depth (RD) with all the measured indices listed as primary outcome
Measured: From surgery to December 2023
Correlation between initial and late measurements of gingival recession width (RW)
Evaluation of mutual correlation of gingival recession width (RW) with all the measured indices listed as primary outcome
Measured: From surgery to December 2023
Correlation between initial and late measurements of gingival recession area (RA)
Evaluation of mutual correlation of gingival recession area (RA) with all the measured indices listed as primary outcome
Measured: From surgery to December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study startJan 1987
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Collaborators
- University of Modena and Reggio Emilia, University of Firenze and Siena, Napoli, Italy, The European Research Group on Periodontology (ERGOPerio)
- Responsible party
- Principal investigator, CARLO BERTOLDI, Azienda Ospedaliero-Universitaria di Modena
- Investigators
- Carlo Bertoldi, MD DDS, Principal investigator, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439382
- Sponsor's protocol ID
- RB008723
- Status last verified
- Feb 2024
- First submitted
- 22 Jun 2022
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rasperini G, Acunzo R, Pellegrini G, Pagni G, Tonetti M, Pini Prato GP, Cortellini P. Predictor factors for long-term outcomes stability of coronally advanced flap with or without connective tissue graft in the treatment of single maxillary gingival recessions: 9 years results of a randomized controlled clinical trial. J Clin Periodontol. 2018 Sep;45(9):1107-1117. doi: 10.1111/jcpe.12932. Epub 2018 Aug 20.
PubMed 29777632Chambrone L, Tatakis DN. Long-Term Outcomes of Untreated Buccal Gingival Recessions: A Systematic Review and Meta-Analysis. J Periodontol. 2016 Jul;87(7):796-808. doi: 10.1902/jop.2016.150625. Epub 2016 Feb 15.
PubMed 26878749Chambrone L, Salinas Ortega MA, Sukekava F, Rotundo R, Kalemaj Z, Buti J, Pini Prato GP. Root coverage procedures for treating localised and multiple recession-type defects. Cochrane Database Syst Rev. 2018 Oct 2;10(10):CD007161. doi: 10.1002/14651858.CD007161.pub3.
PubMed 30277568Pini-Prato GP, Cairo F, Nieri M, Franceschi D, Rotundo R, Cortellini P. Coronally advanced flap versus connective tissue graft in the treatment of multiple gingival recessions: a split-mouth study with a 5-year follow-up. J Clin Periodontol. 2010 Jul;37(7):644-50. doi: 10.1111/j.1600-051X.2010.01559.x. Epub 2010 May 11.
PubMed 20492074Pini Prato GP, Franceschi D, Cortellini P, Chambrone L. Long-term evaluation (20 years) of the outcomes of subepithelial connective tissue graft plus coronally advanced flap in the treatment of maxillary single recession-type defects. J Periodontol. 2018 Nov;89(11):1290-1299. doi: 10.1002/JPER.17-0619. Epub 2018 Aug 10.
PubMed 29873085Francetti L, Weinstein R, Taschieri S, Corbella S. Coronally Advanced Flap With or Without Subepithelial Connective Tissue Graft for the Treatment of Single Recession: 5-Year Outcomes from a Comparative Study. Int J Periodontics Restorative Dent. 2018 November/December;38(6):819-825. doi: 10.11607/prd.3036. Epub 2018 Feb 16.
PubMed 29451926Carvalho PF, da Silva RC, Cury PR, Joly JC. Modified coronally advanced flap associated with a subepithelial connective tissue graft for the treatment of adjacent multiple gingival recessions. J Periodontol. 2006 Nov;77(11):1901-6. doi: 10.1902/jop.2006.050450.
PubMed 17076617Leknes KN, Amarante ES, Price DE, Boe OE, Skavland RJ, Lie T. Coronally positioned flap procedures with or without a biodegradable membrane in the treatment of human gingival recession. A 6-year follow-up study. J Clin Periodontol. 2005 May;32(5):518-29. doi: 10.1111/j.1600-051X.2005.00706.x.
PubMed 15842269Nickles K, Ratka-Kruger P, Neukranz E, Raetzke P, Eickholz P. Ten-year results after connective tissue grafts and guided tissue regeneration for root coverage. J Periodontol. 2010 Jun;81(6):827-36. doi: 10.1902/jop.2010.090632.
PubMed 20450359Kuis D, Sciran I, Lajnert V, Snjaric D, Prpic J, Pezelj-Ribaric S, Bosnjak A. Coronally advanced flap alone or with connective tissue graft in the treatment of single gingival recession defects: a long-term randomized clinical trial. J Periodontol. 2013 Nov;84(11):1576-85. doi: 10.1902/jop.2013.120451. Epub 2013 Feb 22.
PubMed 23432657Zucchelli G, Mounssif I, Mazzotti C, Stefanini M, Marzadori M, Petracci E, Montebugnoli L. Coronally advanced flap with and without connective tissue graft for the treatment of multiple gingival recessions: a comparative short- and long-term controlled randomized clinical trial. J Clin Periodontol. 2014 Apr;41(4):396-403. doi: 10.1111/jcpe.12224. Epub 2014 Jan 22.
PubMed 24382170Jepsen K, Stefanini M, Sanz M, Zucchelli G, Jepsen S. Long-Term Stability of Root Coverage by Coronally Advanced Flap Procedures. J Periodontol. 2017 Jul;88(7):626-633. doi: 10.1902/jop.2017.160767. Epub 2017 Mar 17.
PubMed 28304210Barootchi S, Tavelli L, Di Gianfilippo R, Byun HY, Oh TJ, Barbato L, Cairo F, Wang HL. Long term assessment of root coverage stability using connective tissue graft with or without an epithelial collar for gingival recession treatment. A 12-year follow-up from a randomized clinical trial. J Clin Periodontol. 2019 Nov;46(11):1124-1133. doi: 10.1111/jcpe.13187. Epub 2019 Sep 9.
PubMed 31446625Bertoldi C, Consolo U, Lalla M, Zaffe D, Tanza D, Cairo F, Cortellini P. Long-term stability (21-30 years) of root coverage outcomes using sub-epithelial connective tissue grafts at single or multiple gingival recessions: A longitudinal case series. J Clin Periodontol. 2024 Jan;51(1):2-13. doi: 10.1111/jcpe.13882. Epub 2023 Oct 5.
PubMed 37794814
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very Long-term Analysis of Root Coverage Stability Using Subepithelial Connective Tissue Graft Techniques for Gingival Recession Treatment.
- ClinicalTrials.gov ID
- NCT05439382
- Acronym / sponsor ID
- RB008723
- Conditions
- Gingival Recession, Surgery, Oral Disease
- Keywords
- Gingival recession, Root coverage, Subepithelial tissue graft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Collaborators
- University of Modena and Reggio Emilia, University of Firenze and Siena, Napoli, Italy, The European Research Group on Periodontology (ERGOPerio)
- Study start
- Jan 1987 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Jun 2022 (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.
One-hundred and one healthy participants (221 gingival recessions-GRs) were treated from 1987 to 1996. The probing depth (PD), keratinized tissue width (KTW), gingival recession depth (RD), gingival recession width (RW), gingival recession area (RA) were evaluated and considered at baseline and along time. The obtained data will be evaluated and compared.
Detailed description
Dental-periodontal procedures and clinical measurements.
Dental and periodontal conditions were assessed and treated according to needs in all participants. Emergencies, such as pain or acute dental-periodontal infections, were treated to establish a stable dental-periodontal condition. Cause-related therapy, including patient motivation and professional oral hygiene, was planned and completed.
At the end of cause-related therapy, the following baseline clinical measurements were taken by an investigator: probing depth (PD), keratinized tissue width (KTW), full-mouth plaque scores (FMPS), full-mouth bleeding scores (FMBS), bleeding on probing (BoP), gingival recession depth (RD), gingival recession width (RW), and gingival recession area (RA).
PD and KTW were evaluated using a periodontal probe (University of North Carolina Probe 15 tip) to the nearest 0.5mm. PD was measured at 4 aspects per tooth axially, from the free gingival margin to the most apical part of the sulcus, and, additionally, PD at the mid buccal point; KTW at the mid-buccal point, from the free gingival margin to the mucogingival-junction (MGJ). FMPS was recorded as the percentage of total tooth surfaces (4 aspects per tooth) displaying the presence of plaque, FMBS was calculated as the percentage of total tooth surfaces (4 aspects per tooth) showing bleeding on probing (BoP) was dichotomously assessed.
The bi-dimensional shape of each exposed root surface was reproduced with a lead sheet template. The template had the shape of a triangle with a curved base lining the cemento-enamel-junction (CEJ) and two sides lining the mesial and distal margins of the GR merging at the most apical point of the GR. All templates were measured, coded and stored. The following measurements were recently repeated using an image analysis software: RD, from the most apical point of the triangle to the base; RW, measured at the CEJ level (i.e., at the base of the template) and RA, as the total template area.
These measurements were performed from baseline (before surgery).
Surgery.
All surgical procedures were performed by the same trained operator under local anesthesia.
The recipient site started with an intrasulcular incision on the buccal aspect of the involved teeth. The incision was mesio-distally extended to dissect the buccal aspect of the adjacent papillae. Two oblique releasing incisions were performed from the mesial and distal sides of the horizontal incisions beyond MGJ. A full thickness trapezoid flap, next the dental roots, was raised. Partial dissection was made next the papillae and, apically, at the interproximal places.
After the initial preparation of the recipient site and flap, the bilaminar technique required the withdrawal of palatal connective graft. At the palatal donor site, a horizontal incision was made about 3 mm apical to the free gingival margin. For the epithelial connective tissue graft (ECTG), a second incision was made undermining and splitting the palatal flap. Vertical incisions were carried out mesially and distally joining them to the horizontal incision and performing the palatal flap. Another horizontal incision was made apically on the connective tissue to sever the graft tissue. The graft tissue, 1-1.5 mm thick, was placed in the recipient site to cover the exposed dental roots as far as the CEJ, enlarging mesially and distally on the preserved connective and periosteum of the interproximal sites. Absorbable interrupted and compressive subperiosteal sutures were performed to give stability to the graft. Then, if need to ensure flap mobilization and passivity, a partial thickness dissection was made beyond the MGJ, leaving the underlying periosteum in place and release also the muscle tension, allowing the passive mobilization of the flap that had to cover completely the connective tissue graft (CTG) and the dental roots over the CEJ at least of 2mm. The partial thickness dissection was performed immediately before the graft positioning and suture to avoid flap suffering. The pedicle flap was sutured without residual tension. Each of these surgical techniques could be advantageously used both in cases of single or multiple gingival recessions (GRs).
After surgery, patients were instructed to discontinue toothbrushing of the treated area for 7-10 days. Patients were reinforced to use the roll technique, by soft-bristle toothbrushing outside the treated area during the first month after surgery. Interdental brushes and dental floss in the treated area were forbidden for 1-month. Flap sutures were removed after 7-10 days, and therefore the same toothbrushing prescriptions performed after surgery for outside areas were introduced also in the treated areas. Chlorhexidine rinses were prescribed twice a day for 1 min. About 1-month after surgery, all patients were instructed to resume mechanical tooth cleaning. Patients were recalled for professional supportive care in accordance with Italian health rules and regulations on public dentistry (Essential·Level·of·Assistance - LEA), Law no.·419-30·November·1998, regulating the public dentistry) every 6-24 months whenever possible, and ever in case of need. Patients were recalled for clinical re-evaluations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Langer & Langer technique | – | Procedure: Gingival recession regenerative surgeryParticipants undergoing Langer \& Langer surgical technique |
| Nelson' modified technique | – | Procedure: Gingival recession regenerative surgeryParticipants undergoing Nelson' modified surgical technique |
| Coronally advanced flap and subepithelial graft | – | Procedure: Gingival recession regenerative surgeryParticipants undergoing Coronally advanced flap and subepithelial graft surgical technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants screened for the presence of at least one tooth presenting with gingival recession requiring subepithelial tissue graft (bilaminar technique), examined and treated from 1987 at the Periodontology Unit of Dentistry and Oral-Maxillofacial Surgery of Modena University Hospital.
Key inclusion criteria (3 listed)
- Absence of relevant medical conditions: Medical history of good health. Good oral hygiene: full-mouth plaque score (FMPS) ≤20%. Low level of residual infection: full-mouth bleeding score (FMBS) ≤20%. Participants showing good levels of compliance were selected. Presence of at least one tooth presenting with gingival recession (GR) requiring subepithelial tissue graft, and with identifiable cement-enamel junction (CEJ).
- GR exhibiting an identifiable cemento-enamel junction, and absence of plaque or bleeding on probing (BoP) in the sites scheduled for the procedure.
- GR defects Miller Class I or II without furcation involvement.
Key exclusion criteria (1 listed)
- Pregnant or lactating. Smokers and participants with history of alcohol abuse. 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 |
|---|---|---|
| Gingival recession regenerative surgeryBilaminar technique was performed by the same trained operator, opening a primary flap in correspondence of the recession site. Tissue was harvested from palatal donor site and grafted beneath the primary flap | Procedure or surgery | Coronally advanced flap and subepithelial graft, Langer & Langer technique, Nelson' modified technique |
Primary outcome
Periodontal pocket probing depth (PD)
Time frame: From surgery to December 2023
Measurements of the periodontal pocket depth in millimeters
Keratinized tissue width (KTW)
Time frame: From surgery to December 2023
Measurements of the width of keratinized tissue (gingiva), in millimeters, from the free gingival margin to the mucogingival junction
Gingival recession depth (RD)
Time frame: From surgery to December 2023
Measurements of the depth of the gingival recession, in millimeters, from the cementoenamel junction to the most apical part of the gingival recession
Gingival recession width (RW)
Time frame: From surgery to December 2023
Measurements of the width of the gingival recession, in millimeters, from the mesial to distal part of the uncovered cementoenamel junction
Gingival recession area (RA)
Time frame: From surgery to December 2023
Measurements of the area, in square millimeters, of the gingival recession
5 secondary outcomes
Correlation between initial and late measurements of probing depth (PD)
Time frame: From surgery to December 2023
Correlation between initial and late measurements of keratinized tissue width (KTW)
Time frame: From surgery to December 2023
Correlation between initial and late measurements of gingival recession depth (RD)
Time frame: From surgery to December 2023
Correlation between initial and late measurements of gingival recession width (RW)
Time frame: From surgery to December 2023
Correlation between initial and late measurements of gingival recession area (RA)
Time frame: From surgery to December 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Background: PubMed 29777632Rasperini G, Acunzo R, Pellegrini G, Pagni G, Tonetti M, Pini Prato GP, Cortellini P. Predictor factors for long-term outcomes stability of coronally advanced flap with or without connective tissue graft in the treatment of single maxillary gingival recessions: 9 years results of a randomized controlled clinical trial. J Clin Periodontol. 2018 Sep;45(9):1107-1117. doi: 10.1111/jcpe.12932. Epub 2018 Aug 20.
- Background: PubMed 26878749Chambrone L, Tatakis DN. Long-Term Outcomes of Untreated Buccal Gingival Recessions: A Systematic Review and Meta-Analysis. J Periodontol. 2016 Jul;87(7):796-808. doi: 10.1902/jop.2016.150625. Epub 2016 Feb 15.
- Background: PubMed 30277568Chambrone L, Salinas Ortega MA, Sukekava F, Rotundo R, Kalemaj Z, Buti J, Pini Prato GP. Root coverage procedures for treating localised and multiple recession-type defects. Cochrane Database Syst Rev. 2018 Oct 2;10(10):CD007161. doi: 10.1002/14651858.CD007161.pub3.
- Background: PubMed 20492074Pini-Prato GP, Cairo F, Nieri M, Franceschi D, Rotundo R, Cortellini P. Coronally advanced flap versus connective tissue graft in the treatment of multiple gingival recessions: a split-mouth study with a 5-year follow-up. J Clin Periodontol. 2010 Jul;37(7):644-50. doi: 10.1111/j.1600-051X.2010.01559.x. Epub 2010 May 11.
- Background: PubMed 29873085Pini Prato GP, Franceschi D, Cortellini P, Chambrone L. Long-term evaluation (20 years) of the outcomes of subepithelial connective tissue graft plus coronally advanced flap in the treatment of maxillary single recession-type defects. J Periodontol. 2018 Nov;89(11):1290-1299. doi: 10.1002/JPER.17-0619. Epub 2018 Aug 10.
- Background: PubMed 29451926Francetti L, Weinstein R, Taschieri S, Corbella S. Coronally Advanced Flap With or Without Subepithelial Connective Tissue Graft for the Treatment of Single Recession: 5-Year Outcomes from a Comparative Study. Int J Periodontics Restorative Dent. 2018 November/December;38(6):819-825. doi: 10.11607/prd.3036. Epub 2018 Feb 16.
- Background: PubMed 17076617Carvalho PF, da Silva RC, Cury PR, Joly JC. Modified coronally advanced flap associated with a subepithelial connective tissue graft for the treatment of adjacent multiple gingival recessions. J Periodontol. 2006 Nov;77(11):1901-6. doi: 10.1902/jop.2006.050450.
- Background: PubMed 15842269Leknes KN, Amarante ES, Price DE, Boe OE, Skavland RJ, Lie T. Coronally positioned flap procedures with or without a biodegradable membrane in the treatment of human gingival recession. A 6-year follow-up study. J Clin Periodontol. 2005 May;32(5):518-29. doi: 10.1111/j.1600-051X.2005.00706.x.
- Background: PubMed 20450359Nickles K, Ratka-Kruger P, Neukranz E, Raetzke P, Eickholz P. Ten-year results after connective tissue grafts and guided tissue regeneration for root coverage. J Periodontol. 2010 Jun;81(6):827-36. doi: 10.1902/jop.2010.090632.
- Background: PubMed 23432657Kuis D, Sciran I, Lajnert V, Snjaric D, Prpic J, Pezelj-Ribaric S, Bosnjak A. Coronally advanced flap alone or with connective tissue graft in the treatment of single gingival recession defects: a long-term randomized clinical trial. J Periodontol. 2013 Nov;84(11):1576-85. doi: 10.1902/jop.2013.120451. Epub 2013 Feb 22.
- Background: PubMed 24382170Zucchelli G, Mounssif I, Mazzotti C, Stefanini M, Marzadori M, Petracci E, Montebugnoli L. Coronally advanced flap with and without connective tissue graft for the treatment of multiple gingival recessions: a comparative short- and long-term controlled randomized clinical trial. J Clin Periodontol. 2014 Apr;41(4):396-403. doi: 10.1111/jcpe.12224. Epub 2014 Jan 22.
- Background: PubMed 28304210Jepsen K, Stefanini M, Sanz M, Zucchelli G, Jepsen S. Long-Term Stability of Root Coverage by Coronally Advanced Flap Procedures. J Periodontol. 2017 Jul;88(7):626-633. doi: 10.1902/jop.2017.160767. Epub 2017 Mar 17.
- Individual participant dataSharing planned: No
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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.
Carlo Bertoldi, MD DDS principal investigator
University of Modena and Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Recession and Surgery, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
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 3 inclusion and 1 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 2 Feb 2024. 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 Italy. 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?
Results are not available in the source record.
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?
Periodontal pocket probing depth (PD) (time frame: From surgery to December 2023). The study lists 5 primary outcomes in all. 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 NCT05439382, which also lists 14 linked publications.
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 2 Feb 2024.