Gingival RecessionNCT02276586
Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design
A study testing Horizontal Tooth preparation and Vertical Tooth preparation in people with Gingival Recession and Gingival Disease, run by University of Padova, School of Dental Medicine at 1 site in Italy.
Trial summary
Background: The actual literature is consistent in considering potential negative effects of sub-gingival prosthetic margins on the periodontal health, but no research has focused the attention on the type of prosthetic margin designs. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gingival Recession, Gingival Disease, Gingival Bleeding
- What is being tested?
- Horizontal Tooth preparation and Vertical Tooth preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient inclusion criteria were as follows:
- dentate patients treatment planned for single unit restorations in the esthetic zone (from 1st premolar forward)
- periodontal probing depth prior to tooth preparation ≤4mm, with no bleeding on probing and no plaque
- >30 years of age
- full mouth plaque score (FMPS) and full mouth bleeding scores (FMBS) <20% at study baseline
- eventual loss of attachment limited only to areas different from the sites included in the study.
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- The patient exclusion criteria were as follows:
- patient with medical history in which any dental intervention would be contraindicated
- any local or systemic disease, condition or medication that might compromise healing and affect the periodontium
- dental caries or periodontal disease in the remaining teeth
- inability or unwillingness to return for follow-up visit.
- Exlusion Criteria:
- patients with systemic diseases (such as heart, coagulation, and leukocyte diseases or metabolic disorders)
- history of radiation therapy in the head and neck region within 12 months prior to surgical phase
- current treatment with steroids
- neurological or psychiatric condition that could interfere with good oral hygiene
- immunocompromised status, including infection with human immunodeficiency virus
- smoking habit (more than 10 cigarettes/day)
- drug or alcohol abuse
- inadequate compliance
- patients who received bone regeneration procedure
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Background: The actual literature is consistent in considering potential negative effects of sub-gingival prosthetic margins on the periodontal health, but no research has focused the attention on the type of prosthetic margin designs. Hence, the aim of the present study is to evaluate if a horizontal finishing line (deep chamfer preparation) may have a different influence on periodontal soft tissue in comparison with a vertical finishing line (feather edge preparation).
Methods: A prospective randomized controlled double blind clinical trial with one single operator and three experienced examiners was performed. One hundred and six crowns were prepared with horizontal tooth preparation while ninety-four with vertical tooth preparation. All the margins were positioned within the periodontal sulcus, at 0.5mm sub-gingivally and all the all-ceramic restorations were cemented with resin cement. Periodontal Probing Depth (PPD), Plaque Index (PI), Gingival Index (GI) and Gingival Bleeding on Probing (BOP) were recorded prior to tooth preparation and twelve month after crown cementation. Also, at 12 months follow-up, the gingival margin position was related to the crown margin position.
- Conditions
- Gingival Recession, Gingival Disease, Gingival Bleeding
- Being tested
- Horizontal Tooth preparation, Vertical Tooth preparation
- Medical subject headings
- Gingival Recession, Gingival Diseases, Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizontal Tooth preparationProcedure or surgery
Round parallel chamfer diamond burs were used for teeth preparation; coarse first (151 micron) and extra-fine after (25 micron)
Vertical Tooth preparationProcedure or surgery
Long flame diamond burs were used for teeth preparation; coarse first (151 micron) and extra-fine after (25 micron)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Horizontal Tooth preparation Receives: Procedure: Horizontal Tooth preparation |
| Group 2 | Experimental | Vertical tooth preparation Receives: Procedure: Vertical Tooth preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index (PI)
Plaque Index (PI), according to Silness \& Loe
Measured: Change from Baseline Plaque Index at 12 months post intervention
Periodontal Probing Depth (PPD)
Periodontal Probing Depth (PPD) measured at three different facial sites (mesial, facial, distal), with the utilization of a periodontal probe (UNC periodontal probe, Hu-Friedy, Chicago, IL) recording the measurements to the nearest millimeter.
Measured: Change from Baseline Periodontal Probing Depth (PPD) at 12 months post intervention
Gingival Index (GI)
Gingival Index (GI), according to Silness \& Loe
Measured: Change from Baseline Gingival Index (GI) at 12 months post intervention
Bleeding on Probing (BOP)
Bleeding on Probing (BOP), according to Ainamo \& Bay (presence or absence)
Measured: Change from Baseline Bleeding on Probing (BOP) at 12 months post intervention
Gingival recession (GR)
Gingival margin position related to the crown margin
Measured: Change from Baseline Gingival recession (GR) at 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startJan 2013
- Primary completionJul 2014
- Study completionSep 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova, School of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eriberto Bressan, University of Padova, School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276586
- Sponsor's protocol ID
- 2737P
- Status last verified
- Oct 2014
- First submitted
- 9 Oct 2014
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design
- ClinicalTrials.gov ID
- NCT02276586
- Acronym / sponsor ID
- 2737P
- Conditions
- Gingival Recession, Gingival Disease, Gingival Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Padova, School of Dental MedicineUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 28 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.
Background: The actual literature is consistent in considering potential negative effects of sub-gingival prosthetic margins on the periodontal health, but no research has focused the attention on the type of prosthetic margin designs. Hence, the aim of the present study is to evaluate if a horizontal finishing line (deep chamfer preparation) may have a different influence on periodontal soft tissue in comparison with a vertical finishing line (feather edge preparation).
Methods: A prospective randomized controlled double blind clinical trial with one single operator and three experienced examiners was performed. One hundred and six crowns were prepared with horizontal tooth preparation while ninety-four with vertical tooth preparation. All the margins were positioned within the periodontal sulcus, at 0.5mm sub-gingivally and all the all-ceramic restorations were cemented with resin cement. Periodontal Probing Depth (PPD), Plaque Index (PI), Gingival Index (GI) and Gingival Bleeding on Probing (BOP) were recorded prior to tooth preparation and twelve month after crown cementation. Also, at 12 months follow-up, the gingival margin position was related to the crown margin position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Horizontal Tooth preparationHorizontal Tooth preparation |
| Group 2 | Experimental | Procedure: Vertical Tooth preparationVertical tooth preparation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- dentate patients treatment planned for single unit restorations in the esthetic zone (from 1st premolar forward)
- periodontal probing depth prior to tooth preparation ≤4mm, with no bleeding on probing and no plaque
- >30 years of age
- full mouth plaque score (FMPS) and full mouth bleeding scores (FMBS) <20% at study baseline
- eventual loss of attachment limited only to areas different from the sites included in the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Horizontal Tooth preparationRound parallel chamfer diamond burs were used for teeth preparation; coarse first (151 micron) and extra-fine after (25 micron) | Procedure or surgery | Group 1 |
| Vertical Tooth preparationLong flame diamond burs were used for teeth preparation; coarse first (151 micron) and extra-fine after (25 micron) | Procedure or surgery | Group 2 |
Primary outcome
Plaque Index (PI)
Time frame: Change from Baseline Plaque Index at 12 months post intervention
Plaque Index (PI), according to Silness \& Loe
Periodontal Probing Depth (PPD)
Time frame: Change from Baseline Periodontal Probing Depth (PPD) at 12 months post intervention
Periodontal Probing Depth (PPD) measured at three different facial sites (mesial, facial, distal), with the utilization of a periodontal probe (UNC periodontal probe, Hu-Friedy, Chicago, IL) recording the measurements to the nearest millimeter.
Gingival Index (GI)
Time frame: Change from Baseline Gingival Index (GI) at 12 months post intervention
Gingival Index (GI), according to Silness \& Loe
Bleeding on Probing (BOP)
Time frame: Change from Baseline Bleeding on Probing (BOP) at 12 months post intervention
Bleeding on Probing (BOP), according to Ainamo \& Bay (presence or absence)
Gingival recession (GR)
Time frame: Change from Baseline Gingival recession (GR) at 12 months post intervention
Gingival margin position related to the crown margin
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 28 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 Horizontal Tooth preparation and Vertical Tooth preparation in people with Gingival Recession and Gingival Disease, 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 21 inclusion and 0 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 28 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?
Plaque Index (PI) (time frame: Change from Baseline Plaque Index at 12 months post intervention). 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?
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 28 Oct 2014.