Gingival Recession Localized ModerateNCT04082130
Xenogenic Collagen Matrix and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recession
A study testing (XCM)+(CAF) and (SCTG)+(CAF) in people with Gingival Recession Localized Moderate, run by Damascus University at 1 site in Syria.
Trial summary
this study is a Clinical evaluation of using Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) compared to subepithelial connective tissue graft (SCTG) plus coronally advanced flap to treat Miller class I gingival recession. Read more about this study
- Who is it for?
- Ages 18 to 47 years
- Conditions the study is for
- Gingival Recession Localized Moderate
- What is being tested?
- (XCM)+(CAF) and (SCTG)+(CAF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSyria
- Study dates
- 25 Aug 2019to 1 Aug 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 to 47 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Good general health.
- No contraindications for periodontal surgery.
- Presence of one localized gingival recession in each side of the maxilla and/or mandible, All recessions will be Class I defects (Miller 1985).
- The cemento-enamel junction (CEJ) is visible in the defective teeth.
- All patients demonstrating good plaque control.
- No previous periodontal surgery in the targeted area.
Who cannot join
- Smokers.
- pregnant or nursing patients.
- history of malignancy, radiotherapy, or chemotherapy.
- Patients taking medications that affect mucosal healing.
- Patients with allergy to collagen.
- Previous participation in a clinical trial.
- Type-1 diabetes patients.
- Patient who have diseases that affect connective tissue metabolism.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Periodontics, University of Damascus Dental School
Damascus, Syrian Arab Republic, DM20AM18
About this study
Official title: Clinical Comparison of Coronally-advanced Flap Plus Xenogeneic Collagen Matrix (Fibro-Gide®) and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recessions
this study is a Clinical evaluation of using Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) compared to subepithelial connective tissue graft (SCTG) plus coronally advanced flap to treat Miller class I gingival recession. A split-full-split thickness flap will be elevated in the (XCM+CAF) group while it will be an only partial thickness flap in the (SCTG+CAF) group. The sample size will be 15 patients. Each patient has bilateral Miller Class I gingival recessions; and as a split-mouth study design one side will be treated with (SCTG+CAF), while the other will be treated with (XCM+CAF).
Read the detailed description
The aim of this study is to clinically compare between the subepithelial connective tissue graft (SCTG) plus coronally advanced flap (CAF) which is defined as the golden standard for the treatment of gingival recessions and Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) to treat class I Miller gingival recession. CAF elevation will be done as it described by (De Sanctis \& Zucchelli 2007) with modifications in the the control group.The flap will be partially elevated in the (SCTG+CAF) group while it will be a split-full-split thickness flap in the (XCM+CAF) group, and finally the flap will stabilized coronally. Fifteen patients who have bilateral buccal Miller Class I gingival recession defects will be enrolled in this study. These defects will be distributed randomly into two groups: the test group (XCM+CAF) and control group (SCTG+CAF). Clinical parameters will be evaluated: Recession depth (REC), change in visible plaque index, recession width (RW), width of keratinized tissue (KT), thickness of gingival tissue (GT), probing depth (PD), clinical attachment level (CAL), healing index (HI), questionnaires will be given to evaluate each of patient perceptions, pain index (PI), and changes in root sensitivity by using visual analog scale (VAS).
- Conditions
- Gingival Recession Localized Moderate
- Being tested
- (XCM)+(CAF), (SCTG)+(CAF)
- Keywords
- Xenogenic collagen matrix (XCM)., subepithelial connective tissue graft (SCGT)., coronally advanced flap (CAF)., Root coverage.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(XCM)+(CAF)Procedure or surgery
The description of this intervention has been already given before.
(SCTG)+(CAF)Procedure or surgery
The description of this intervention has been already given before.
| Study group | Role | What they receive |
|---|---|---|
| (XCM)+(CAF) | Experimental | Surgical protocol for test treatment with CAF + XCM:
After local anesthetizing the recipient site,CAF elevation will be done using (De Sanctis \& Zucchelli 2007) design.Horizontal incisions will be done at the recession site,another two slightly divergent vertical incisions will be done at the end of previous incisions extending to the mucogingival junction.The resulting flap will be split thickness in the surgical papillae area,then will be full thickness exposing 3-4 mm of the bone apically of the dehiscence and after that it will be split thickness in the apical direction,all the muscle insertions will be eliminated,the root surface will be prepared by curettes and chemically treated with 24% EDTA gel.De-epithelialization of the interdental papillae will be done.The XCM will be trimmed and fix onto the root surface 1-2mm coronally of the CEJ using absorbable sutures,and the flap will be coronally advanced to fully cover the XCM and then sutured to the de-epithelialized papillae. Receives: Procedure: (XCM)+(CAF) |
| (SCTG)+(CAF) | Active comparator | The surgical protocol in the control group will be identical with test group protocol with these exceptions:
1. The entire flap will be elevated as split thickness instead of split-full-split thickness flap.
2. A SCTG harvested from the palate will be used to cover the exposed denuded root surface in lieu of placement of XCM in the test group. And absorbable sutures will be used to stabilize it 2 mm coronally from the CEJ.
3. As in the test group the mucosal flap will coronally advanced to completely cover the SCTG then sutured to the de-epithelialized papillae. Receives: Procedure: (SCTG)+(CAF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession depth (REC): (Change in the amount of root coverage)
from the free gingival margin to the cemento-enamel junction at the mid-buccal aspect. Using University of North Carolina periodontal probe UNC15 (Medesey®-Italy).
Measured: 1)At baseline, 2) 2 weeks post-surgery, 3) At 1 month post-surgery and 4) 3 months post-surgery.
Secondary outcomes (10)
change in visible plaque index:
- Score 0 - No plaque
- Score 1 - Separate flecks of plaque at the cervical margin of the tooth
- Score 2 - A thin continuous band of plaque at the cervical margin of the tooth
- Score 3 - A band of plaque wider then 1mm covering less than 1/3rd of the crown of the tooth
- Score 4 - Plaque covering at least 1/3rd but less than 2/3rd of the crown of the tooth
- Score 5 - Plaque covering 2/3rd or more of the crown of the tooth
Measured: 1) baseline, 2) at 2 weeks postoperative,3) 1 month and 4) 3 month postoperative
Recession width (RW)
at the cemento-enamel junction using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
Measured: 1) at baseline, 2) at 2 weeks postoperative, 3) at 1 month postoperative, 4) and at 3 months postoperative.
Width of keratinized tissue (KT)
from the free gingival margin to the mucogingival junction using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
Measured: 1) baseline, 2) 2 weeks postoperative, 3) 1 month postoperative and 4) 3 months postoperative.
Thickness of gingival tissue (GT)
with an injection needle and a silicon marker, at the mid-buccal aspect below the gingival margin.
Measured: 1) at baseline, and 2) 3 months postoperative.
Probing depth (PD)
the distance between the gingival margin and the bottom of the pocket measured at the mid-buccal aspect of the tooth using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
Measured: 1) at baseline, 2) and 3 months postoperative.
Clinical attachment level (CAL)
distance between the CEJ and the bottom of the pocket measured at the mid-buccal aspect of the tooth using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).
Measured: 1) at baseline, 2) at 3 months postoperative.
Healing index
score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence.
score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration.
score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.
Measured: 1) at two weeks following surgery and (2) at one month following surgery.
Pain index (PI)
Using Visual Analogue scale (VAS) (2001 Crichton), Patients will be asked to select among 100 scores (0 indicating no pain at all , 50 indicating average pain, and 100 indicating very painful).
Measured: 1) at 2 hours, 2) 24 hours, 3) 48 hours,4) 72 hours following surgery and 5) at 1-week after surgery.
Patient Perceptions
Using 100 cm Visual Analogue Scale (VAS)Patients will be asked to select among 100 scores (0 indicating very bad, 50 indicating average, and 100 indicating excellent results).
Measured: at three months post-surgery.
Change in root sensitivity
Using a 100 cm-visual analog scale (VAS), patients' root sensitivity will be recorded with zero indicating no pain or sensitivity, 50 indicating moderate pain or sensitivity and 100 indicating worst pain or sensitivity possible.
Measured: 1) at baseline, 2) and at 3 months postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start25 Aug 2019
- Primary completion30 Jun 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession Localized ModerateStudies 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
- Crossover
- Model description
- split-mouth design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noor Alhuda Ewaz Ali, DDS, Principal investigator, MSc student in Periodontics, University of Damascus Dental SchoolSuleiman Dayoub, DDS MSc PhD, Study chair, Professor of Periodontics, University of Damascus Dental SchoolMohammad Alharissy, DDS MSc PhD, Study director, Assistant Professor of Periodontics, Academic Staff Member At Wadi International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082130
- Sponsor's protocol ID
- UDDS-Perio-01-2019
- Status last verified
- Jan 2021
- First submitted
- 28 Aug 2019
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim HJ, Chang H, Kim S, Seol YJ, Kim HI. Periodontal biotype modification using a volume-stable collagen matrix and autogenous subepithelial connective tissue graft for the treatment of gingival recession: a case series. J Periodontal Implant Sci. 2018 Dec 27;48(6):395-404. doi: 10.5051/jpis.2018.48.6.395. eCollection 2018 Dec.
PubMed 30619640Matoh U, Petelin M, Gaspersic R. Split-Mouth Comparison of Coronally Advanced Flap with Connective Tissue Graft or Collagen Matrix for Treatment of Isolated Gingival Recessions. Int J Periodontics Restorative Dent. 2019 May/Jun;39(3):439-446. doi: 10.11607/prd.3562.
PubMed 30986293Jepsen 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 28304210Lafzi A, Abolfazli N, Faramarzi M, Eyvazi M, Eskandari A, Salehsaber F. Clinical comparison of coronally-advanced flap plus amniotic membrane or subepithelial connective tissue in the treatment of Miller's class I and II gingival recessions: A split-mouth study. J Dent Res Dent Clin Dent Prospects. 2016;10(3):162-8. doi: 10.15171/joddd.2016.026. Epub 2016 Aug 17.
PubMed 27651882Rasperini 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 29777632Stefanini M, Jepsen K, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M, Jepsen S, Zucchelli G. Patient-reported outcomes and aesthetic evaluation of root coverage procedures: a 12-month follow-up of a randomized controlled clinical trial. J Clin Periodontol. 2016 Dec;43(12):1132-1141. doi: 10.1111/jcpe.12626. Epub 2016 Nov 7.
PubMed 27717210Zucchelli G, Mele M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Coronally advanced flap with and without vertical releasing incisions for the treatment of multiple gingival recessions: a comparative controlled randomized clinical trial. J Periodontol. 2009 Jul;80(7):1083-94. doi: 10.1902/jop.2009.090041.
PubMed 19563288Stefanini M, Zucchelli G, Marzadori M, de Sanctis M. Coronally Advanced Flap with Site-Specific Application of Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recessions: A 3-Year Follow-Up Case Series. Int J Periodontics Restorative Dent. 2018 Jan/Feb;38(1):25-33. doi: 10.11607/prd.3438.
PubMed 29240201Tatakis DN, Trombelli L. Gingival recession treatment: guided tissue regeneration with bioabsorbable membrane versus connective tissue graft. J Periodontol. 2000 Feb;71(2):299-307. doi: 10.1902/jop.2000.71.2.299.
PubMed 10711621Chambrone L, de Castro Pinto RCN, Chambrone LA. The concepts of evidence-based periodontal plastic surgery: Application of the principles of evidence-based dentistry for the treatment of recession-type defects. Periodontol 2000. 2019 Feb;79(1):81-106. doi: 10.1111/prd.12248.
PubMed 30892767Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival recession defects with a coronally advanced flap and a xenogeneic collagen matrix: a multicenter randomized clinical trial. J Clin Periodontol. 2013 Jan;40(1):82-9. doi: 10.1111/jcpe.12019. Epub 2012 Oct 10.
PubMed 23050490de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.
PubMed 17309597
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Coronally-advanced Flap Plus Xenogeneic Collagen Matrix (Fibro-Gide®) and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recessions
- ClinicalTrials.gov ID
- NCT04082130
- Acronym / sponsor ID
- UDDS-Perio-01-2019
- Conditions
- Gingival Recession Localized Moderate
- Keywords
- Xenogenic collagen matrix (XCM)., subepithelial connective tissue graft (SCGT)., coronally advanced flap (CAF)., Root coverage.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 25 Aug 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 9 Sep 2019 (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.
this study is a Clinical evaluation of using Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) compared to subepithelial connective tissue graft (SCTG) plus coronally advanced flap to treat Miller class I gingival recession. A split-full-split thickness flap will be elevated in the (XCM+CAF) group while it will be an only partial thickness flap in the (SCTG+CAF) group. The sample size will be 15 patients. Each patient has bilateral Miller Class I gingival recessions; and as a split-mouth study design one side will be treated with (SCTG+CAF), while the other will be treated with (XCM+CAF).
Detailed description
The aim of this study is to clinically compare between the subepithelial connective tissue graft (SCTG) plus coronally advanced flap (CAF) which is defined as the golden standard for the treatment of gingival recessions and Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) to treat class I Miller gingival recession. CAF elevation will be done as it described by (De Sanctis \& Zucchelli 2007) with modifications in the the control group.The flap will be partially elevated in the (SCTG+CAF) group while it will be a split-full-split thickness flap in the (XCM+CAF) group, and finally the flap will stabilized coronally. Fifteen patients who have bilateral buccal Miller Class I gingival recession defects will be enrolled in this study. These defects will be distributed randomly into two groups: the test group (XCM+CAF) and control group (SCTG+CAF). Clinical parameters will be evaluated: Recession depth (REC), change in visible plaque index, recession width (RW), width of keratinized tissue (KT), thickness of gingival tissue (GT), probing depth (PD), clinical attachment level (CAL), healing index (HI), questionnaires will be given to evaluate each of patient perceptions, pain index (PI), and changes in root sensitivity by using visual analog scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- split-mouth design.
| Arm | Type | Receives |
|---|---|---|
| (XCM)+(CAF) | Experimental | Procedure: (XCM)+(CAF)Surgical protocol for test treatment with CAF + XCM: After local anesthetizing the recipient site,CAF elevation will be done using (De Sanctis \& Zucchelli 2007) design.Horizontal incisions will be done at the recession site,another two slightly divergent vertical incisions will be done at the end of previous incisions extending to the mucogingival junction.The resulting flap will be split thickness in the surgical papillae area,then will be full thickness exposing 3-4 mm of the bone apically of the dehiscence and after that it will be split thickness in the apical direction,all the muscle insertions will be eliminated,the root surface will be prepared by curettes and chemically treated with 24% EDTA gel.De-epithelialization of the interdental papillae will be done.The XCM will be trimmed and fix onto the root surface 1-2mm coronally of the CEJ using absorbable sutures,and the flap will be coronally advanced to fully cover the XCM and then sutured to the de-epithelialized papillae. |
| (SCTG)+(CAF) | Active comparator | Procedure: (SCTG)+(CAF)The surgical protocol in the control group will be identical with test group protocol with these exceptions: 1. The entire flap will be elevated as split thickness instead of split-full-split thickness flap. 2. A SCTG harvested from the palate will be used to cover the exposed denuded root surface in lieu of placement of XCM in the test group. And absorbable sutures will be used to stabilize it 2 mm coronally from the CEJ. 3. As in the test group the mucosal flap will coronally advanced to completely cover the SCTG then sutured to the de-epithelialized papillae. |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Good general health.
- No contraindications for periodontal surgery.
- Presence of one localized gingival recession in each side of the maxilla and/or mandible, All recessions will be Class I defects (Miller 1985).
- The cemento-enamel junction (CEJ) is visible in the defective teeth.
- All patients demonstrating good plaque control.
Key exclusion criteria (8 listed)
- Smokers.
- pregnant or nursing patients.
- history of malignancy, radiotherapy, or chemotherapy.
- Patients taking medications that affect mucosal healing.
- Patients with allergy to collagen.
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 |
|---|---|---|
| (XCM)+(CAF)The description of this intervention has been already given before. | Procedure or surgery | (XCM)+(CAF) |
| (SCTG)+(CAF)The description of this intervention has been already given before. | Procedure or surgery | (SCTG)+(CAF) |
Primary outcome
Recession depth (REC): (Change in the amount of root coverage)
Time frame: 1)At baseline, 2) 2 weeks post-surgery, 3) At 1 month post-surgery and 4) 3 months post-surgery.
from the free gingival margin to the cemento-enamel junction at the mid-buccal aspect. Using University of North Carolina periodontal probe UNC15 (Medesey®-Italy).
10 secondary outcomes
change in visible plaque index:
Time frame: 1) baseline, 2) at 2 weeks postoperative,3) 1 month and 4) 3 month postoperative
Recession width (RW)
Time frame: 1) at baseline, 2) at 2 weeks postoperative, 3) at 1 month postoperative, 4) and at 3 months postoperative.
Width of keratinized tissue (KT)
Time frame: 1) baseline, 2) 2 weeks postoperative, 3) 1 month postoperative and 4) 3 months postoperative.
Thickness of gingival tissue (GT)
Time frame: 1) at baseline, and 2) 3 months postoperative.
Probing depth (PD)
Time frame: 1) at baseline, 2) and 3 months postoperative.
Clinical attachment level (CAL)
Time frame: 1) at baseline, 2) at 3 months postoperative.
Healing index
Time frame: 1) at two weeks following surgery and (2) at one month following surgery.
Pain index (PI)
Time frame: 1) at 2 hours, 2) 24 hours, 3) 48 hours,4) 72 hours following surgery and 5) at 1-week after surgery.
Patient Perceptions
Time frame: at three months post-surgery.
Change in root sensitivity
Time frame: 1) at baseline, 2) and at 3 months postoperative.
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 12 Jan 2021.
- Background: PubMed 30619640Kim HJ, Chang H, Kim S, Seol YJ, Kim HI. Periodontal biotype modification using a volume-stable collagen matrix and autogenous subepithelial connective tissue graft for the treatment of gingival recession: a case series. J Periodontal Implant Sci. 2018 Dec 27;48(6):395-404. doi: 10.5051/jpis.2018.48.6.395. eCollection 2018 Dec.
- Background: PubMed 30986293Matoh U, Petelin M, Gaspersic R. Split-Mouth Comparison of Coronally Advanced Flap with Connective Tissue Graft or Collagen Matrix for Treatment of Isolated Gingival Recessions. Int J Periodontics Restorative Dent. 2019 May/Jun;39(3):439-446. doi: 10.11607/prd.3562.
- 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.
- Background: PubMed 27651882Lafzi A, Abolfazli N, Faramarzi M, Eyvazi M, Eskandari A, Salehsaber F. Clinical comparison of coronally-advanced flap plus amniotic membrane or subepithelial connective tissue in the treatment of Miller's class I and II gingival recessions: A split-mouth study. J Dent Res Dent Clin Dent Prospects. 2016;10(3):162-8. doi: 10.15171/joddd.2016.026. Epub 2016 Aug 17.
- 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 27717210Stefanini M, Jepsen K, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M, Jepsen S, Zucchelli G. Patient-reported outcomes and aesthetic evaluation of root coverage procedures: a 12-month follow-up of a randomized controlled clinical trial. J Clin Periodontol. 2016 Dec;43(12):1132-1141. doi: 10.1111/jcpe.12626. Epub 2016 Nov 7.
- Background: PubMed 19563288Zucchelli G, Mele M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Coronally advanced flap with and without vertical releasing incisions for the treatment of multiple gingival recessions: a comparative controlled randomized clinical trial. J Periodontol. 2009 Jul;80(7):1083-94. doi: 10.1902/jop.2009.090041.
- Background: PubMed 29240201Stefanini M, Zucchelli G, Marzadori M, de Sanctis M. Coronally Advanced Flap with Site-Specific Application of Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recessions: A 3-Year Follow-Up Case Series. Int J Periodontics Restorative Dent. 2018 Jan/Feb;38(1):25-33. doi: 10.11607/prd.3438.
- Background: PubMed 10711621Tatakis DN, Trombelli L. Gingival recession treatment: guided tissue regeneration with bioabsorbable membrane versus connective tissue graft. J Periodontol. 2000 Feb;71(2):299-307. doi: 10.1902/jop.2000.71.2.299.
- Background: PubMed 30892767Chambrone L, de Castro Pinto RCN, Chambrone LA. The concepts of evidence-based periodontal plastic surgery: Application of the principles of evidence-based dentistry for the treatment of recession-type defects. Periodontol 2000. 2019 Feb;79(1):81-106. doi: 10.1111/prd.12248.
- Background: PubMed 23050490Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival recession defects with a coronally advanced flap and a xenogeneic collagen matrix: a multicenter randomized clinical trial. J Clin Periodontol. 2013 Jan;40(1):82-9. doi: 10.1111/jcpe.12019. Epub 2012 Oct 10.
- Background: PubMed 17309597de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.
- 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.
Noor Alhuda Ewaz Ali, DDS principal investigator
MSc student in Periodontics, University of Damascus Dental School
Suleiman Dayoub, DDS MSc PhD study chair
Professor of Periodontics, University of Damascus Dental School
Mohammad Alharissy, DDS MSc PhD study director
Assistant Professor of Periodontics, Academic Staff Member At Wadi International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (XCM)+(CAF) and (SCTG)+(CAF) in people with Gingival Recession Localized Moderate, run by Damascus University at 1 site in Syria.
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 6 inclusion and 8 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 12 Jan 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 Syria. 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?
Recession depth (REC): (Change in the amount of root coverage) (time frame: 1)At baseline, 2) 2 weeks post-surgery, 3) At 1 month post-surgery and 4) 3 months post-surgery.). 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 NCT04082130, which also lists 12 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 12 Jan 2021.