Periodontal DebridementNCT02013661
Clinical Evaluation of Sutures in Periodontal Surgery
An observational study of Periodontal Debridement, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The aims of this study were to evaluate and compare tissue erythema, edema and knot loosening among four types of suture one week after periodontal surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Debridement
- What is being tested?
- Periodontal resective surgery
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2011to Jun 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients treated at the CUO (dental clinic at the Universitat Internacional de Catalunya) that are prescribed for periodontal resective surgery
Who may be able to join
- Qualification for the study was based on the need for resective periodontal surgery (apically positioned flap and osseous recontouring) at four or more consecutive interproximal sites per quadrant
Who cannot join
- systemic diseases, such as diabetes, chronic obstructive pulmonary disease, or an immunologic disease that would affect wound healing; allergies to prescribed medication; and/or current pregnancy or breast feeding were excluded from the study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Internacional de Catalunya
San Cugat Del Valles, Barcelona, 08195
About this study
Official title: Clinical Evaluation of Four Types of Suture in Periodontal Surgery
The aims of this study were to evaluate and compare tissue erythema, edema and knot loosening among four types of suture one week after periodontal surgery.
Read the detailed description
Forty patients participated in this prospective, randomized, double-blind clinical trial. Vertical mattress sutures were used following resective periodontal surgery performed by one operator. Four suture materials were selected for evaluation: 5-0 silk; 5-0 polypropylene; 5-0 polyglycolic acid (PGA), and 4-0 polytetrafluoroethylene (PTFE). Seven days after the surgical procedure, the surgeon assessed suture loosening and removed the sutures. A blind researcher clinically evaluated erythema and edema.
- Conditions
- Periodontal Debridement
- Being tested
- Periodontal resective surgery
- Keywords
- periodontal debridement, sutures, tissue reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal resective surgeryProcedure or surgery
surgical periodontal debridement is performed after periodontal phase I
| Study group | Role | What they receive |
|---|---|---|
| Suture in Periodontal resective surgery | Four types of suture including silk, polypropylene, PGA, and PTFE Receives: Procedure: Periodontal resective surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence or absence of Suture loosening
Seven days after the surgical procedure, the surgeon assessed suture loosening; recording loose or not Loose
Measured: seven days after surgery
Secondary outcomes (1)
presence and level of erythema and edema.
Seven days after the surgical procedure a blind researcher clinically evaluated erythema and edema. Adding a score related to a gingival index
Measured: seven days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DebridementStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Almudena Tasende Pereiro, Universitat Internacional de Catalunya
- Investigators
- Jose Nart, DDS, PhD, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013661
- Sponsor's protocol ID
- C-12-ASA-10
- Status last verified
- Dec 2013
- First submitted
- 27 Nov 2013
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Four Types of Suture in Periodontal Surgery
- ClinicalTrials.gov ID
- NCT02013661
- Acronym / sponsor ID
- C-12-ASA-10
- Conditions
- Periodontal Debridement
- Keywords
- periodontal debridement, sutures, tissue reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Dec 2013 (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 aims of this study were to evaluate and compare tissue erythema, edema and knot loosening among four types of suture one week after periodontal surgery.
Detailed description
Forty patients participated in this prospective, randomized, double-blind clinical trial. Vertical mattress sutures were used following resective periodontal surgery performed by one operator. Four suture materials were selected for evaluation: 5-0 silk; 5-0 polypropylene; 5-0 polyglycolic acid (PGA), and 4-0 polytetrafluoroethylene (PTFE). Seven days after the surgical procedure, the surgeon assessed suture loosening and removed the sutures. A blind researcher clinically evaluated erythema and edema.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suture in Periodontal resective surgery | – | Procedure: Periodontal resective surgeryFour types of suture including silk, polypropylene, PGA, and PTFE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated at the CUO (dental clinic at the Universitat Internacional de Catalunya) that are prescribed for periodontal resective surgery
Key inclusion criteria (1 listed)
- Qualification for the study was based on the need for resective periodontal surgery (apically positioned flap and osseous recontouring) at four or more consecutive interproximal sites per quadrant
Key exclusion criteria (1 listed)
- systemic diseases, such as diabetes, chronic obstructive pulmonary disease, or an immunologic disease that would affect wound healing; allergies to prescribed medication; and/or current pregnancy or breast feeding were excluded from the study
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 |
|---|---|---|
| Periodontal resective surgerysurgical periodontal debridement is performed after periodontal phase I | Procedure or surgery | Suture in Periodontal resective surgery |
Primary outcome
presence or absence of Suture loosening
Time frame: seven days after surgery
Seven days after the surgical procedure, the surgeon assessed suture loosening; recording loose or not Loose
1 secondary outcome
presence and level of erythema and edema.
Time frame: seven days after surgery
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 17 Dec 2013.
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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.
Jose Nart, DDS, PhD principal investigator
Universitat Internacional de Catalunya
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 Periodontal Debridement, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 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 17 Dec 2013. 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 Spain. 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?
presence or absence of Suture loosening (time frame: seven days after surgery). 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 17 Dec 2013.