Gingival RecessionNCT02788266
Treatment of Gingival Recession-type Defects Using Different Restorative Materials
A study testing connective tissue graft+composite resin, connective tissue graft+ glass ionomer and connective tissue graft+giomer in people with Gingival Recession and Tooth Abrasion, run by Gazi University.
Trial summary
Background: The aim of this study was to evaluate the treatment of multiple gingival recessions associated with non-carious cervical lesions (NCCL) using a modified coronally advanced flap in combination with a sub-epithelial connective tissue graft (SCTG) on restored root surfaces. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Tooth Abrasion
- What is being tested?
- connective tissue graft+composite resin, connective tissue graft+ glass ionomer and connective tissue graft+giomer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Feb 2016
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Positive for the presence of three cervical lesions associated with multiple gingival recessions in three different adjacent teeth excluding molars;
- Miller Class I gingival recession defect (≥2 and ≤5 mm) associated with buccal NCCL (lesion depth 1-2 mm);
- Non-smoker;
- Systemically and periodontally healthy;
- Not taking medications known to interfere with periodontal tissue health or healing;
- Probing depth (PD)≤3 mm;
- Presence of ≥1 mm highly keratinized tissue apical to the root exposure, and presence of ≥0.8 mm-thick gingival tissue;
- Absence of non-vital teeth, caries or restorations on cervical areas, severe occlusal interferences and previous surgery in the area.
Who cannot join
- inflammatory periodontal disease; previous surgical attempt to correct gingival recession; systemic disease or severe immune deficiency; coagulation defect or current anticoagulation treatment; addiction to drugs; inability or unwillingness to complete the trial; lack of linguistic skills; psychiatric disorders; refusal to sign the informed consent form; pregnancy; molar or premolar teeth with furcation involvement.
About this study
Official title: Clinical Evaluation of Combined Surgical/ Restorative Treatment of Gingival Recession-type Defects Using Different Restorative Materials
Background: The aim of this study was to evaluate the treatment of multiple gingival recessions associated with non-carious cervical lesions (NCCL) using a modified coronally advanced flap in combination with a sub-epithelial connective tissue graft (SCTG) on restored root surfaces.
Methods: Twenty-three systemically healthy subjects, who were positive for the presence of three cervical lesions associated with gingival recessions in three different adjacent teeth, were enrolled in the study. The NCCL were each restored prior to surgery by using one of three different materials: composite resin (group 1), resin-modified glass ionomer cement (group 2) or giomer (group 3). The defects were treated with SCTG. Clinical measurements, including plaque index (PI), bleeding on probing (BOP), relative recession height (rRH), probing depth (PD), cervical lesion height (CLH), relative clinical attachment level (rCAL), keratinized tissue height (KTH), keratinized tissue thickness (KTT), percentage of root coverage (RC), and percentage of cervical lesion height coverage (CLHC) were recorded at baseline, 3 and 6 months, and 1 year postoperatively.
Read the detailed description
Gingival recession (GR) is defined as exposure of the root surface due to displacement of the gingival margin apical to the cemento-enamel junction (CEJ). Problems related to gingival recessions are dentin hypersensitivity, bacterial plaque accumulation, difficulty of maintaining oral health care and aesthetics, root caries and abrasions and fear of losing teeth6. Coronally advanced flap (CAF) is an effective periodontal plastic surgical procedure for the treatment of gingival recessions. The CAF with a subepithelial connective tissue graft (CAF+ SCTG) technique is reported as the gold standard and does enhance the probability of achieving complete root coverage.
Various dental materials and surgical approaches have been used to manage gingival recessions associated with cervical lesions for the most predictable combined surgical/restorative treatment.Restorative materials must be biocompatible to minimize their adverse effects on periodontal tissues induced by direct contact.Resin composites or resin modified glass ionomer cements have been commonly used to restore cervical lesions.Resin-ionomer materials have many properties such as biocompatibility with soft and hard tissues and displaying high marginal adaptation and minimal surface roughness as well as allowing them to be used successfully in the subgingival region. Composite resin materials have many advantages including aesthetics and surface characteristics in terms of finishing and polishing.
It has been reported that well-adapted and finished composite resins seem have no adverse effects on the periodontal margin. It has also been reported that the ageing of the composite resin restorations may produce gingival inflammation in subgingival areas. Fluoride-releasing resin materials with pre-reacted glass (PRG), called giomer, has been suggested to have good color matching, biocompatibility, smooth surface finish, fluoride release and fluoride recharge potential. It was reported in a randomized-controlled clinical trial that the use of CTG for treatment of root surfaces restored with giomer was effective over the 6-month period without any noxious effect on periodontal tissues.
Therefore, the aim of this study was to evaluate clinically the treatment of gingival recession associated with NCCL in resin modified glass ionomer cement (RMGI) or nano-filled resin composite (NRC) or giomer plus SCTG in the first year following surgery.
- Conditions
- Gingival Recession, Tooth Abrasion
- Being tested
- connective tissue graft+composite resin, connective tissue graft+ glass ionomer, connective tissue graft+giomer
- Keywords
- Cervical lesion, gingival recession, restorative materials
- Medical subject headings
- Gingival Recession, Tooth Abrasion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
connective tissue graft+composite resinProcedure or surgery
treatment of gingival recession associated with cervical lesions with sub epithelial connective tissue graft plus composite resin
connective tissue graft+ glass ionomerProcedure or surgery
treatment of gingival recession associated with cervical lesions with sub epithelial connective tissue graft plus resin modified glass ionomer cement
connective tissue graft+giomerProcedure or surgery
treatment of gingival recession associated with cervical lesions with sub epithelial connective tissue graft plus giomer
| Study group | Role | What they receive |
|---|---|---|
| connective tissue graft+composite resin | Active comparator | connective tissue graft plus composite resin Receives: Procedure: connective tissue graft+composite resin |
| connective tissue graft+ glass ionomer | Active comparator | connective tissue graft plus resin modified glass ionomer cement Receives: Procedure: connective tissue graft+ glass ionomer |
| connective tissue graft+giomer | Active comparator | connective tissue graft plus giomer Receives: Procedure: connective tissue graft+giomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
relative gingival recession height
measured as distance from the most apical point of gingival margin to the incisional border of the tooth
Measured: one year post-op
Secondary outcomes (1)
keratinized tissue width
measured from most apical point of the gingival margin to the mucogingival junction
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startDec 2013
- Primary completionJan 2016
- Study completionFeb 2016
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.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sıla Çağrı İşler, Gazi University
- Investigators
- gonen ozcan, Ph D, Study director, Prof.dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788266
- Sponsor's protocol ID
- 25901600-7587
- Status last verified
- May 2016
- First submitted
- 27 May 2016
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Combined Surgical/ Restorative Treatment of Gingival Recession-type Defects Using Different Restorative Materials
- ClinicalTrials.gov ID
- NCT02788266
- Acronym / sponsor ID
- 25901600-7587
- Conditions
- Gingival Recession, Tooth Abrasion
- Keywords
- Cervical lesion, gingival recession, restorative materials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 2 Jun 2016 (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.
Background: The aim of this study was to evaluate the treatment of multiple gingival recessions associated with non-carious cervical lesions (NCCL) using a modified coronally advanced flap in combination with a sub-epithelial connective tissue graft (SCTG) on restored root surfaces.
Methods: Twenty-three systemically healthy subjects, who were positive for the presence of three cervical lesions associated with gingival recessions in three different adjacent teeth, were enrolled in the study. The NCCL were each restored prior to surgery by using one of three different materials: composite resin (group 1), resin-modified glass ionomer cement (group 2) or giomer (group 3). The defects were treated with SCTG. Clinical measurements, including plaque index (PI), bleeding on probing (BOP), relative recession height (rRH), probing depth (PD), cervical lesion height (CLH), relative clinical attachment level (rCAL), keratinized tissue height (KTH), keratinized tissue thickness (KTT), percentage of root coverage (RC), and percentage of cervical lesion height coverage (CLHC) were recorded at baseline, 3 and 6 months, and 1 year postoperatively.
Detailed description
Gingival recession (GR) is defined as exposure of the root surface due to displacement of the gingival margin apical to the cemento-enamel junction (CEJ). Problems related to gingival recessions are dentin hypersensitivity, bacterial plaque accumulation, difficulty of maintaining oral health care and aesthetics, root caries and abrasions and fear of losing teeth6. Coronally advanced flap (CAF) is an effective periodontal plastic surgical procedure for the treatment of gingival recessions. The CAF with a subepithelial connective tissue graft (CAF+ SCTG) technique is reported as the gold standard and does enhance the probability of achieving complete root coverage.
Various dental materials and surgical approaches have been used to manage gingival recessions associated with cervical lesions for the most predictable combined surgical/restorative treatment.Restorative materials must be biocompatible to minimize their adverse effects on periodontal tissues induced by direct contact.Resin composites or resin modified glass ionomer cements have been commonly used to restore cervical lesions.Resin-ionomer materials have many properties such as biocompatibility with soft and hard tissues and displaying high marginal adaptation and minimal surface roughness as well as allowing them to be used successfully in the subgingival region. Composite resin materials have many advantages including aesthetics and surface characteristics in terms of finishing and polishing.
It has been reported that well-adapted and finished composite resins seem have no adverse effects on the periodontal margin. It has also been reported that the ageing of the composite resin restorations may produce gingival inflammation in subgingival areas. Fluoride-releasing resin materials with pre-reacted glass (PRG), called giomer, has been suggested to have good color matching, biocompatibility, smooth surface finish, fluoride release and fluoride recharge potential. It was reported in a randomized-controlled clinical trial that the use of CTG for treatment of root surfaces restored with giomer was effective over the 6-month period without any noxious effect on periodontal tissues.
Therefore, the aim of this study was to evaluate clinically the treatment of gingival recession associated with NCCL in resin modified glass ionomer cement (RMGI) or nano-filled resin composite (NRC) or giomer plus SCTG in the first year following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| connective tissue graft+composite resin | Active comparator | Procedure: connective tissue graft+composite resinconnective tissue graft plus composite resin |
| connective tissue graft+ glass ionomer | Active comparator | Procedure: connective tissue graft+ glass ionomerconnective tissue graft plus resin modified glass ionomer cement |
| connective tissue graft+giomer | Active comparator | Procedure: connective tissue graft+giomerconnective tissue graft plus giomer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Positive for the presence of three cervical lesions associated with multiple gingival recessions in three different adjacent teeth excluding molars;
- Miller Class I gingival recession defect (≥2 and ≤5 mm) associated with buccal NCCL (lesion depth 1-2 mm);
- Non-smoker;
- Systemically and periodontally healthy;
- Not taking medications known to interfere with periodontal tissue health or healing;
Key exclusion criteria (1 listed)
- inflammatory periodontal disease; previous surgical attempt to correct gingival recession; systemic disease or severe immune deficiency; coagulation defect or current anticoagulation treatment; addiction to drugs; inability or unwillingness to complete the trial; lack of linguistic skills; psychiatric disorders; refusal to sign the informed consent form; pregnancy; molar or premolar teeth with furcation involvement.
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 |
|---|---|---|
| connective tissue graft+composite resintreatment of gingival recession associated with cervical lesions with sub epithelial connective tissue graft plus composite resin | Procedure or surgery | connective tissue graft+composite resin |
| connective tissue graft+ glass ionomertreatment of gingival recession associated with cervical lesions with sub epithelial connective tissue graft plus resin modified glass ionomer cement | Procedure or surgery | connective tissue graft+ glass ionomer |
| connective tissue graft+giomertreatment of gingival recession associated with cervical lesions with sub epithelial connective tissue graft plus giomer | Procedure or surgery | connective tissue graft+giomer |
Primary outcome
relative gingival recession height
Time frame: one year post-op
measured as distance from the most apical point of gingival margin to the incisional border of the tooth
1 secondary outcome
keratinized tissue width
Time frame: one year
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 2 Jun 2016.
- Individual participant dataSharing planned: No
Related trials for Gingival Recession
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i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
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Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
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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.
gonen ozcan, Ph D study director
Prof.dr.
Questions about this trial
What is this clinical trial studying?
A study testing connective tissue graft+composite resin, connective tissue graft+ glass ionomer and connective tissue graft+giomer in people with Gingival Recession and Tooth Abrasion, run by Gazi University.
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 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: finished, as of the sponsor's last update on 2 Jun 2016. 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. 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?
relative gingival recession height (time frame: one year post-op). 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 2 Jun 2016.