Gingival RecessionNCT02269748
Morbidity and Coverage Outcome With Connective Tissue Graft Used With Coronally Advanced Flap and Tunneling Technique
A study testing Tunnel technique with subepithelial connective tissue, Coronally advanced flap and Analgesic Therapy in people with Gingival Recession, run by University of Padova, School of Dental Medicine at 1 site in Italy.
Trial summary
The aim of this randomized-controlled clinical trial is to compare the patient morbidity and root coverage outcomes of a sub-epithelial connective tissue (SeCTG) used in combination with a coronally advanced flap (CAF) and tunnel technique (TT). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Tunnel technique with subepithelial connective tissue, Coronally advanced flap and Analgesic Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2012to Jun 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single Miller's Class I or Class II recession defects 2 to 4 mm range of recession height will be included presence of identifiable cemento enamel junction (CEJ) presence of a root abrasion, but with an identifiable CEJ, will be accepted; periodontally and systemically healthy no contraindications for periodontal surgery no taking medications known to interfere with periodontal tissue health or healing no periodontal surgery on the involved sites.
Who cannot join
- Subjects smoking more than 10 cigarettes a day will be excluded. Recession defects associated with caries or restoration as well as teeth with evidence of a pulpal pathology will not be included.
- Molar teeth will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Morbidity and Root Coverage Outcome After Subepithelial Connective Tissue Graft Used in Combination With Coronally Advanced Flap and Tunneling Technique: a Comparative Randomized Controlled Clinical Trial.
The aim of this randomized-controlled clinical trial is to compare the patient morbidity and root coverage outcomes of a sub-epithelial connective tissue (SeCTG) used in combination with a coronally advanced flap (CAF) and tunnel technique (TT).
The primary objective of the study is to demonstrate the superiority in terms of the post-operative course and pain of the CAF+SeCTG when compared to the TT.
Read the detailed description
The aim of this randomized-controlled clinical trial is to compare the patient morbidity and root coverage outcomes of a sub-epithelial connective tissue (SeCTG) used in combination with a coronally advanced flap (CAF) and tunnel technique (TT).
The study will be designed as a single-centre, randomized, clinical trial on the treatment of single gingival recessions. The study assessed two different treatment modalities: the tunnel technique with subepithelial connective tissue graft (TT), compared to the coronally advanced flap with subepithelial connective tissue graft (CAF+SeCTG) in terms of clinical outcomes, and post operative morbidity.
50 patients with one gingival recession each will be treated. Evaluation of patient morbidity will be performed 3 days and 1 week after the surgery. Clinical outcomes will be evaluated 12 months post operatively. Clinical outcomes included percentage of root coverage (RC) and complete root coverage (CRC) will be recorded. Patient morbidity will be evaluated with questionnaires.
Clinical measurements (1 week before surgery and at the 12 months follow-up)
- Gingival recession height (GH)
- Probing depth (PD)
- Clinical attachment level (CAL)
- Height of keratinized tissue (KTH)
Patient morbidity
- Quantity of analgesics taken during the first week post-surgery.
- Patients' post operative discomfort, bleeding, stress and inability to chew was evaluated with a questionnaire given to patients 3 days following surgery.
Kolmogorov-Smirnov test will be used to analyze distribution of continuous variables. Continuous variables are expressed as means ± standard deviation (SD) and compared at baseline by the U Mann-Whitney test. This test will be also used to compare mean changes post vs. baseline measurements. The Wilcoxon test will be used to compare post vs. baseline measurements. Spearman correlation will be used to evaluate associations.
Level of significance was set at 0.05. The SPSS v. 20 software (SPSS Inc., Chicago, IL, USA) will be used for all analyses.
- Conditions
- Gingival Recession
- Being tested
- Tunnel technique with subepithelial connective tissue, Coronally advanced flap, Analgesic Therapy
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tunnel technique with subepithelial connective tissueProcedure or surgery
Also called root coverage procedure with tunnel technique
After harvesting a connective tissue graft from the palate, the graft is placed under a gingival tunnel prepared over the donor site.
Coronally advanced flapProcedure or surgery
Also called Coronally advanced flap with sub epithelial connective tissue graft
After harvesting a connective tissue graft from the palate, the graft is placed under a gingival flap which is repositioned coronally
Analgesic TherapyDrug
Ibuprofen 600 mg TID
| Study group | Role | What they receive |
|---|---|---|
| Root coverage with Tunnel (TT) | Experimental | The tunnel technique with subepithelial connective tissue graft (TT+SeCTG) will be utilized to cover the denude root surface Receives: Procedure: Tunnel technique with subepithelial connective tissue; Drug: Analgesic Therapy |
| Coronally advanced flap (CAF+SeCTG) | Active comparator | The Coronally advanced flap with subepithelial connective tissue graft (CAF+SeCTG) will be utilized to cover the denude root surface Receives: Procedure: Coronally advanced flap; Drug: Analgesic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient morbidity
Quantity of analgesics taken during the first week post-surgery. Patients' post operative discomfort, bleeding, stress and inability to chew was evaluated with a questionnaire given to patients 3 days following surgery.
Measured: 3 days after intervention
Secondary outcomes (4)
Clinical measurements GH
Gingival recession height (GH)
Measured: 12 months follow-up
Clinical measurements PD
Probing depth (PD)
Measured: 12 months follow-up
Clinical measurements CAL
clinical attachment level (CAL)
Measured: 12 months follow-up
Clinical measurements KTH
height of keratinized tissue (KTH)
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startApr 2012
- Primary completionJun 2014
- Study completionJun 2014
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova, School of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Gobbato, University of Padova, School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269748
- Sponsor's protocol ID
- 2566P
- Status last verified
- Oct 2014
- First submitted
- 15 Oct 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Morbidity and Root Coverage Outcome After Subepithelial Connective Tissue Graft Used in Combination With Coronally Advanced Flap and Tunneling Technique: a Comparative Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT02269748
- Acronym / sponsor ID
- 2566P
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Padova, School of Dental MedicineUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Oct 2014 (estimated)
- 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.
The aim of this randomized-controlled clinical trial is to compare the patient morbidity and root coverage outcomes of a sub-epithelial connective tissue (SeCTG) used in combination with a coronally advanced flap (CAF) and tunnel technique (TT).
The primary objective of the study is to demonstrate the superiority in terms of the post-operative course and pain of the CAF+SeCTG when compared to the TT.
Detailed description
The aim of this randomized-controlled clinical trial is to compare the patient morbidity and root coverage outcomes of a sub-epithelial connective tissue (SeCTG) used in combination with a coronally advanced flap (CAF) and tunnel technique (TT).
The study will be designed as a single-centre, randomized, clinical trial on the treatment of single gingival recessions. The study assessed two different treatment modalities: the tunnel technique with subepithelial connective tissue graft (TT), compared to the coronally advanced flap with subepithelial connective tissue graft (CAF+SeCTG) in terms of clinical outcomes, and post operative morbidity.
50 patients with one gingival recession each will be treated. Evaluation of patient morbidity will be performed 3 days and 1 week after the surgery. Clinical outcomes will be evaluated 12 months post operatively. Clinical outcomes included percentage of root coverage (RC) and complete root coverage (CRC) will be recorded. Patient morbidity will be evaluated with questionnaires.
Clinical measurements (1 week before surgery and at the 12 months follow-up)
- Gingival recession height (GH)
- Probing depth (PD)
- Clinical attachment level (CAL)
- Height of keratinized tissue (KTH)
Patient morbidity
- Quantity of analgesics taken during the first week post-surgery.
- Patients' post operative discomfort, bleeding, stress and inability to chew was evaluated with a questionnaire given to patients 3 days following surgery.
Kolmogorov-Smirnov test will be used to analyze distribution of continuous variables. Continuous variables are expressed as means ± standard deviation (SD) and compared at baseline by the U Mann-Whitney test. This test will be also used to compare mean changes post vs. baseline measurements. The Wilcoxon test will be used to compare post vs. baseline measurements. Spearman correlation will be used to evaluate associations.
Level of significance was set at 0.05. The SPSS v. 20 software (SPSS Inc., Chicago, IL, USA) will be used for all analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Root coverage with Tunnel (TT) | Experimental | Procedure: Tunnel technique with subepithelial connective tissue, Drug: Analgesic TherapyThe tunnel technique with subepithelial connective tissue graft (TT+SeCTG) will be utilized to cover the denude root surface |
| Coronally advanced flap (CAF+SeCTG) | Active comparator | Procedure: Coronally advanced flap, Drug: Analgesic TherapyThe Coronally advanced flap with subepithelial connective tissue graft (CAF+SeCTG) will be utilized to cover the denude root surface |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Single Miller's Class I or Class II recession defects 2 to 4 mm range of recession height will be included presence of identifiable cemento enamel junction (CEJ) presence of a root abrasion, but with an identifiable CEJ, will be accepted; periodontally and systemically healthy no contraindications for periodontal surgery no taking medications known to interfere with periodontal tissue health or healing no periodontal surgery on the involved sites.
Key exclusion criteria (2 listed)
- Subjects smoking more than 10 cigarettes a day will be excluded. Recession defects associated with caries or restoration as well as teeth with evidence of a pulpal pathology will not be included.
- Molar teeth will also be excluded.
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 |
|---|---|---|
| Tunnel technique with subepithelial connective tissueAlso: root coverage procedure with tunnel techniqueAfter harvesting a connective tissue graft from the palate, the graft is placed under a gingival tunnel prepared over the donor site. | Procedure or surgery | Root coverage with Tunnel (TT) |
| Coronally advanced flapAlso: Coronally advanced flap with sub epithelial connective tissue graftAfter harvesting a connective tissue graft from the palate, the graft is placed under a gingival flap which is repositioned coronally | Procedure or surgery | Coronally advanced flap (CAF+SeCTG) |
| Analgesic TherapyIbuprofen 600 mg TID | Drug | Coronally advanced flap (CAF+SeCTG), Root coverage with Tunnel (TT) |
Primary outcome
Patient morbidity
Time frame: 3 days after intervention
Quantity of analgesics taken during the first week post-surgery. Patients' post operative discomfort, bleeding, stress and inability to chew was evaluated with a questionnaire given to patients 3 days following surgery.
4 secondary outcomes
Clinical measurements GH
Time frame: 12 months follow-up
Clinical measurements PD
Time frame: 12 months follow-up
Clinical measurements CAL
Time frame: 12 months follow-up
Clinical measurements KTH
Time frame: 12 months follow-up
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 21 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tunnel technique with subepithelial connective tissue, Coronally advanced flap and Analgesic Therapy in people with Gingival Recession, run by University of Padova, School of Dental Medicine 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 1 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 21 Oct 2014. 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?
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?
Patient morbidity (time frame: 3 days after intervention). 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 21 Oct 2014.