PainPhase 2NCT01986959
Periodontal Dressing After Surgical Crown Lengthening
A Phase 2 study testing With Periodontal dressing and Without Periodontal dressing in people with Pain and Wound Healing Disturbance of, run by Franciscan University Center at 1 site in Brazil.
Trial summary
Background: There is controversy regarding the postoperative effects of periodontal dressing on the periodontium, pain and discomfort. The aim of the present study was to compare postoperative pain following surgical crown lengthening with and without the use of periodontal dressing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Wound Healing Disturbance of, Periodontal Infection
- What is being tested?
- With Periodontal dressing and Without Periodontal dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2011to Oct 2012
- Phase
- Phase 2
- 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
Who may be able to join
- need for surgical crown lengthening on only one tooth with need for proximal osteotomy;
- aged 18 years or older;
- absence of systemic disease;
- absence of periodontal disease at the site of surgical crown lengthening;
- no restrictions regarding the procedure;
- no need for antimicrobial prophylaxis.
Who cannot join
- failure to return for the postoperative evaluations;
- failure to fill out the charts correctly;
- occurrence of pulp alteration in the operated tooth following the procedure;
- occurrence of partial or total loss of the periodontal dressing;
- allergic reaction to periodontal dressing.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry, Franciscan University Center
Santa Maria, Rio Grande do Sul, 97010-491
About this study
Official title: Periodontal Dressing After Surgical Crown Lengthening: A Randomized Clinical Trial
Background: There is controversy regarding the postoperative effects of periodontal dressing on the periodontium, pain and discomfort. The aim of the present study was to compare postoperative pain following surgical crown lengthening with and without the use of periodontal dressing.
Material and Methods: A blind, randomized, clinical trial was carried out with 36 patients. Following surgical crown lengthening, the individuals were randomly allocated to the periodontal dressing group (PDG) and control group (CG - non-placement of periodontal dressing). Pain and discomfort were analyzed using a visual analog scale (VAS), verbal scale (VS) and the number of analgesics consumed in seven days postoperatively. Postoperative infection, stability of the gingival margin and type of healing were also evaluated.
- Conditions
- Pain, Wound Healing Disturbance of, Periodontal Infection
- Being tested
- With Periodontal dressing, Without Periodontal dressing
- Keywords
- Periodontal Dressings, Surgical crown lengthening, Periodontal surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With Periodontal dressingProcedure or surgery
Also called Coe-PakTM Regular (GC AMERICA INC, Alsip, IL, USA)
After surgery,the dressing was mixed with a sterile spatula on a sterile glass plate following the manufacturer's instructions (2 cm of each paste measured with a sterile endodontic ruler). Coe-PakTM Regular was the dressing employed. Mixing and placement were performed only by the specialists in periodontics to ensure standardization. The dressing was inserted into the surgical wounds and molded to the necessary shape after setting sufficiently. The removal of the periodontal dressing was done after seven days.
Without Periodontal dressingProcedure or surgery
The dressing was not inserted.
| Study group | Role | What they receive |
|---|---|---|
| Surgery with Periodontal dressing | Experimental | After the Surgical crown lengthening, the patients were randomly allocated to the periodontal dressing group (PDG) and control group (CG - non-placement of periodontal dressing). Receives: Procedure: With Periodontal dressing |
| Surgery without Periodontal dressing | Other | After surgery, the patients were randomly allocated to the periodontal dressing group (PDG) and control group (CG - non-placement of periodontal dressing). Receives: Procedure: Without Periodontal dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Position of the gingival margin
Following removal of the dressing, the examiner determined the position of the gingival margin. This position was determined individually using the same procedure performed in the immediate postoperative period based on the previously recorded fixed reference points. The determination of gingival recession, position of the gingival margin and gingival swelling was performed categorically, using the gingival margin in the immediate postoperative period for comparison.
Measured: Seven days
Secondary outcomes (4)
Local infection
Infection was defined as present if the patient has at the surgical site, postoperative pain around the site, which increased in intensity at any time between 1 and 3 days after the procedure, with or without the presence of halitosis.
Measured: seven Days
Healing
The healing of the surgical wound was evaluated based on the type of migration of the free edges of epithelium. Healing by first intention was determined by the migration of the epithelium toward the bed of the wound. Cases in which an area of conjunctive tissue and/or bone was uncovered by epithelium and re-epithelialization by the adjacent epithelium was occurring were classified as healing by second intention
Measured: Seven Days
Pain and discomfort
A questionnaire for the evaluation of pain and sensitivity on the first, second, third and seventh days postoperatively was given to each patient to fill out at home. All evaluations involved a record of the number of analgesics taken as well as a visual analog scale (VAS, ranging from 0 [absence of pain] to 100 [unbearable pain] mm) and a verbal scale (VS) with the following responses: no pain; mild pain; moderate pain; severe pain; and very severe pain. The patients were instructed to fill out the scales between 8 and 9 pm every day. Following removal of the dressing, in seven days, the examiner administered the pain scales (VAS and VS).
Measured: Seven days
Gingival bleeding
Following removal of the dressing, the examiner determined the presence of gingival bleeding as present or absent (Ainamo and Bay, 1975.
Measured: Seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franciscan University Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Pippi Antoniazzi, Franciscan University Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986959
- Sponsor's protocol ID
- Periodontal dressing 1246
- Status last verified
- Nov 2013
- First submitted
- 27 Oct 2013
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Dressing After Surgical Crown Lengthening: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01986959
- Acronym / sponsor ID
- Periodontal dressing 1246
- Conditions
- Pain, Wound Healing Disturbance of, Periodontal Infection
- Keywords
- Periodontal Dressings, Surgical crown lengthening, Periodontal surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Franciscan University CenterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 19 Nov 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.
Background: There is controversy regarding the postoperative effects of periodontal dressing on the periodontium, pain and discomfort. The aim of the present study was to compare postoperative pain following surgical crown lengthening with and without the use of periodontal dressing.
Material and Methods: A blind, randomized, clinical trial was carried out with 36 patients. Following surgical crown lengthening, the individuals were randomly allocated to the periodontal dressing group (PDG) and control group (CG - non-placement of periodontal dressing). Pain and discomfort were analyzed using a visual analog scale (VAS), verbal scale (VS) and the number of analgesics consumed in seven days postoperatively. Postoperative infection, stability of the gingival margin and type of healing were also evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery with Periodontal dressing | Experimental | Procedure: With Periodontal dressingAfter the Surgical crown lengthening, the patients were randomly allocated to the periodontal dressing group (PDG) and control group (CG - non-placement of periodontal dressing). |
| Surgery without Periodontal dressing | Other | Procedure: Without Periodontal dressingAfter surgery, the patients were randomly allocated to the periodontal dressing group (PDG) and control group (CG - non-placement of periodontal dressing). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- need for surgical crown lengthening on only one tooth with need for proximal osteotomy;
- aged 18 years or older;
- absence of systemic disease;
- absence of periodontal disease at the site of surgical crown lengthening;
- no restrictions regarding the procedure;
Key exclusion criteria (5 listed)
- failure to return for the postoperative evaluations;
- failure to fill out the charts correctly;
- occurrence of pulp alteration in the operated tooth following the procedure;
- occurrence of partial or total loss of the periodontal dressing;
- allergic reaction to periodontal dressing.
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 |
|---|---|---|
| With Periodontal dressingAlso: Coe-PakTM Regular (GC AMERICA INC, Alsip, IL, USA)After surgery,the dressing was mixed with a sterile spatula on a sterile glass plate following the manufacturer's instructions (2 cm of each paste measured with a sterile endodontic ruler). Coe-PakTM Regular was the dressing employed. Mixing and placement were performed only by the specialists in periodontics to ensure standardization. The dressing was inserted into the surgical wounds and molded to the necessary shape after setting sufficiently. The removal of the periodontal dressing was done after seven days. | Procedure or surgery | Surgery with Periodontal dressing |
| Without Periodontal dressingThe dressing was not inserted. | Procedure or surgery | Surgery without Periodontal dressing |
Primary outcome
Position of the gingival margin
Time frame: Seven days
Following removal of the dressing, the examiner determined the position of the gingival margin. This position was determined individually using the same procedure performed in the immediate postoperative period based on the previously recorded fixed reference points. The determination of gingival recession, position of the gingival margin and gingival swelling was performed categorically, using the gingival margin in the immediate postoperative period for comparison.
4 secondary outcomes
Local infection
Time frame: seven Days
Healing
Time frame: Seven Days
Pain and discomfort
Time frame: Seven days
Gingival bleeding
Time frame: Seven days
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 19 Nov 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.
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 Phase 2 study testing With Periodontal dressing and Without Periodontal dressing in people with Pain and Wound Healing Disturbance of, run by Franciscan University Center at 1 site in Brazil.
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 5 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 19 Nov 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Position of the gingival margin (time frame: Seven days). 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 19 Nov 2013.