Gingival OvergrowthNCT03435068
Soft Tissue Wound Healing Following Different Gingivectomy Techniques
A study testing Ceramic rotary bur, Diode laser and Scalpel in people with Gingival Overgrowth, run by T.C. Dumlupınar Üniversitesi.
Trial summary
The aim of this study was to evaluate the degree of clinical discomfort and the issues experienced by patients and to use a software image program to compare wound healing during the 2-week period following gingivectomy performed with different techniques. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Overgrowth
- What is being tested?
- Ceramic rotary bur, Diode laser and Scalpel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 30 Nov 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The criteria for inclusion in the study were as follows:
- systemically healthy individuals
- nonsmokers
- horizontal and vertical gingival overgrowth indexes with a "score 1" or "score 2"
- mean bleeding on probing and mean plaque index value < 20% (indicating good oral hygiene)
- no clinical attachment loss and
- a minimum of four teeth at each surgical site.
Who cannot join
- The exclusion criteria were as follows:
- systemic disease that could influence the outcome of the treatment, -pregnancy and/or lactation,
- allergy,
- conditions requiring antibiotic prophylaxis and anti-inflammatory medications, -acute or untreated periodontitis
- the use of an analgesic before the surgical procedure.
About this study
Official title: The Evaluation of Soft Tissue Wound Healing Following Different Gingivectomy Applications: A Prospective Randomized Clinical Trial
The aim of this study was to evaluate the degree of clinical discomfort and the issues experienced by patients and to use a software image program to compare wound healing during the 2-week period following gingivectomy performed with different techniques.
Read the detailed description
Horizontal and vertical gingival overgrowth indexes were evaluated before and after surgery during each follow-up controls. The vertical distance of gingival tissue was measured from the gingival margin to the cement-enamel junction (gingival overgrowth [GO] index). Horizontal gingival values were also recorded between the tooth surfaces and the papillary tissue surface at the interdental contact point as buccolingual aspect (mesiobuccal [MB] index).
Postoperative Evaluations
The postoperative parameters, including pain, burning, edema, vascularization, erythema, epithelization, bleeding and carbonization, were recorded at 1, 3, 5, 7, and 14 days postoperatively.
Postoperative pain, burning, erythema, vascularization, and edema were assessed via the visual analogue scale (VAS). The VAS is a 100-mm horizontal-line scale that is used to quantify subjective symptoms such as pain, burning, erythema, vascularization, and edema. In the present study, researchers used a standard VAS on which patients drew a vertical sign along a 10-cm scale from 0 (no pain) to 10 (highest degree of pain). Bleeding and carbonization during the postoperative period were assessed as either present or absent. Patients evaluated their postoperative pain, burning, and bleeding values. The same researcher evaluated erythema, vascularization, edema, and epithelization values.
Evaluation of Surgical Wound Area After gingivectomy operation, the surgical site was evaluated with hydrogen peroxide to detect the presence of epithelization. A blinded researcher who used a standard digital camera to take standard magnification photographs assessed the operation area, consisting of the epithelium. The researcher examined all photographs with the assistance of an image-analyzing software program. The mesio-distal width of the maxillary right central tooth was recorded for each patient, and photographs were calibrated via the reference values. In the areas subjected to hydrogen peroxide application and experiencing tissue reaction, there was a lack of an epithelial layer in the wound area. The wound surface areas of foamy fields on the all of the groups' photographs were recorded on days 1, 3, 5, 7, and 14 following the gingivectomies.
- Conditions
- Gingival Overgrowth
- Being tested
- Ceramic rotary bur, Diode laser, Scalpel
- Keywords
- rotary, diode laser, gingivectomy, wound healing
- Medical subject headings
- Gingival Overgrowth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceramic rotary burDevice
Also called Meisenger ceramic rotary bur
Gingivoplasties were performed with the same ceramic burs to easily provide a knife-edge appearance with ceramic rotary bur
Diode laserDevice
Also called SiroLase Advance &Xtend
The fiber optic laser tip had a 320-μm diameter with a 2.8 W output power were used in the study.
ScalpelDevice
Scalpel surgery were performed as control group (conventioanl group).
| Study group | Role | What they receive |
|---|---|---|
| Ceramic rotary bur | Experimental | For the ceramic bur group(Meisenger gingivectomies, ceramic rotary burs were used with 400-rpm rotary systems and with no serum irrigation, per the manufacturer's recommendation. Receives: Device: Ceramic rotary bur |
| Diode laser | Experimental | In the laser group (LG), a diode laser was applied to the operation sites in accordance with the manufacturer's guidelines (2.8 W continuous wave mode, wavelength 980 nm). The fiber optic laser tip had a 320-μm diameter with a 2.8 W output power. The laser never made contact with the gingival tissue. The practice distance did not affect the laser spot size, which was 0.5 cm-1 cm. Smoke associated with the laser application was aspirated from the surgical site. Receives: Device: Diode laser |
| Scalpel | Active comparator | In the scalpel group following the local anesthetic administration, the gingivectomy was performed with a #15 scalpel. Subsequent to the operation, the borderline of gingiva was determined via the use of a pointer dental tweezers, and excessive gingival tissue was then removed with Gracey curettes Receives: Device: Scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative wound healing change
After gingivectomy operation, the surgical site was evaluated with hydrogen peroxide to detect the presence of epithelization
Measured: The wound surface areas of foamy fields on the all of the groups' photographs were recorded change between 1st day and 14th day following the gingivectomies.
Secondary outcomes (3)
Postoperative pain
The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms
Measured: Visual analogue Scale, minimum score is 0 and maximum score is 10.Change of VAS values were recorded on days between 1st and 14th days following the gingivectomies
Postoperative erythema
The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms
Measured: Visual analogue Scale, minimum score is 0 and maximum score is 10.Change of VAS values were recorded on days between 1st and 14th days following the gingivectomies
Postoperative burning
The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms
Measured: Visual analogue Scale, minimum score is 0 and maximum score is 10.Change of VAS values were recorded on days between 1st and 14th days following the gingivectomies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start1 Apr 2016
- Primary completion30 Sep 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gingival OvergrowthStudies 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
- Model description
- The trial is parallel-designed, controlled, prospective clinical study.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- T.C. Dumlupınar Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berceste Guler, T.C. Dumlupınar Üniversitesi
- Investigators
- Ahu Uraz, PhD Dr, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435068
- Sponsor's protocol ID
- 2015-KAEK-86/05-39
- Status last verified
- Feb 2018
- First submitted
- 4 Feb 2018
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giannelli M, Bani D, Tani A, Pini A, Margheri M, Zecchi-Orlandini S, Tonelli P, Formigli L. In vitro evaluation of the effects of low-intensity Nd:YAG laser irradiation on the inflammatory reaction elicited by bacterial lipopolysaccharide adherent to titanium dental implants. J Periodontol. 2009 Jun;80(6):977-84. doi: 10.1902/jop.2009.080648.
PubMed 19485829Tomasi C, Schander K, Dahlen G, Wennstrom JL. Short-term clinical and microbiologic effects of pocket debridement with an Er:YAG laser during periodontal maintenance. J Periodontol. 2006 Jan;77(1):111-8. doi: 10.1902/jop.2006.77.1.111.
PubMed 16579711Favia G, Tempesta A, Limongelli L, Suppressa P, Sabba C, Maiorano E. Diode laser treatment and clinical management of multiple oral lesions in patients with hereditary haemorrhagic telangiectasia. Br J Oral Maxillofac Surg. 2016 May;54(4):379-83. doi: 10.1016/j.bjoms.2015.08.260. Epub 2015 Sep 8.
PubMed 26360009
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Soft Tissue Wound Healing Following Different Gingivectomy Applications: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03435068
- Acronym / sponsor ID
- 2015-KAEK-86/05-39
- Conditions
- Gingival Overgrowth
- Keywords
- rotary, diode laser, gingivectomy, wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- T.C. Dumlupınar ÜniversitesiUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 15 Feb 2018 (actual)
- 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 study was to evaluate the degree of clinical discomfort and the issues experienced by patients and to use a software image program to compare wound healing during the 2-week period following gingivectomy performed with different techniques.
Detailed description
Horizontal and vertical gingival overgrowth indexes were evaluated before and after surgery during each follow-up controls. The vertical distance of gingival tissue was measured from the gingival margin to the cement-enamel junction (gingival overgrowth [GO] index). Horizontal gingival values were also recorded between the tooth surfaces and the papillary tissue surface at the interdental contact point as buccolingual aspect (mesiobuccal [MB] index).
Postoperative Evaluations
The postoperative parameters, including pain, burning, edema, vascularization, erythema, epithelization, bleeding and carbonization, were recorded at 1, 3, 5, 7, and 14 days postoperatively.
Postoperative pain, burning, erythema, vascularization, and edema were assessed via the visual analogue scale (VAS). The VAS is a 100-mm horizontal-line scale that is used to quantify subjective symptoms such as pain, burning, erythema, vascularization, and edema. In the present study, researchers used a standard VAS on which patients drew a vertical sign along a 10-cm scale from 0 (no pain) to 10 (highest degree of pain). Bleeding and carbonization during the postoperative period were assessed as either present or absent. Patients evaluated their postoperative pain, burning, and bleeding values. The same researcher evaluated erythema, vascularization, edema, and epithelization values.
Evaluation of Surgical Wound Area After gingivectomy operation, the surgical site was evaluated with hydrogen peroxide to detect the presence of epithelization. A blinded researcher who used a standard digital camera to take standard magnification photographs assessed the operation area, consisting of the epithelium. The researcher examined all photographs with the assistance of an image-analyzing software program. The mesio-distal width of the maxillary right central tooth was recorded for each patient, and photographs were calibrated via the reference values. In the areas subjected to hydrogen peroxide application and experiencing tissue reaction, there was a lack of an epithelial layer in the wound area. The wound surface areas of foamy fields on the all of the groups' photographs were recorded on days 1, 3, 5, 7, and 14 following the gingivectomies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The trial is parallel-designed, controlled, prospective clinical study.
| Arm | Type | Receives |
|---|---|---|
| Ceramic rotary bur | Experimental | Device: Ceramic rotary burFor the ceramic bur group(Meisenger gingivectomies, ceramic rotary burs were used with 400-rpm rotary systems and with no serum irrigation, per the manufacturer's recommendation. |
| Diode laser | Experimental | Device: Diode laserIn the laser group (LG), a diode laser was applied to the operation sites in accordance with the manufacturer's guidelines (2.8 W continuous wave mode, wavelength 980 nm). The fiber optic laser tip had a 320-μm diameter with a 2.8 W output power. The laser never made contact with the gingival tissue. The practice distance did not affect the laser spot size, which was 0.5 cm-1 cm. Smoke associated with the laser application was aspirated from the surgical site. |
| Scalpel | Active comparator | Device: ScalpelIn the scalpel group following the local anesthetic administration, the gingivectomy was performed with a #15 scalpel. Subsequent to the operation, the borderline of gingiva was determined via the use of a pointer dental tweezers, and excessive gingival tissue was then removed with Gracey curettes |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- systemically healthy individuals
- nonsmokers
- horizontal and vertical gingival overgrowth indexes with a "score 1" or "score 2"
- mean bleeding on probing and mean plaque index value < 20% (indicating good oral hygiene)
- no clinical attachment loss and
Key exclusion criteria (5 listed)
- systemic disease that could influence the outcome of the treatment, -pregnancy and/or lactation,
- allergy,
- conditions requiring antibiotic prophylaxis and anti-inflammatory medications, -acute or untreated periodontitis
- the use of an analgesic before the surgical procedure.
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 |
|---|---|---|
| Ceramic rotary burAlso: Meisenger ceramic rotary burGingivoplasties were performed with the same ceramic burs to easily provide a knife-edge appearance with ceramic rotary bur | Device | Ceramic rotary bur |
| Diode laserAlso: SiroLase Advance &XtendThe fiber optic laser tip had a 320-μm diameter with a 2.8 W output power were used in the study. | Device | Diode laser |
| ScalpelScalpel surgery were performed as control group (conventioanl group). | Device | Scalpel |
Primary outcome
Postoperative wound healing change
Time frame: The wound surface areas of foamy fields on the all of the groups' photographs were recorded change between 1st day and 14th day following the gingivectomies.
After gingivectomy operation, the surgical site was evaluated with hydrogen peroxide to detect the presence of epithelization
3 secondary outcomes
Postoperative pain
Time frame: Visual analogue Scale, minimum score is 0 and maximum score is 10.Change of VAS values were recorded on days between 1st and 14th days following the gingivectomies
Postoperative erythema
Time frame: Visual analogue Scale, minimum score is 0 and maximum score is 10.Change of VAS values were recorded on days between 1st and 14th days following the gingivectomies
Postoperative burning
Time frame: Visual analogue Scale, minimum score is 0 and maximum score is 10.Change of VAS values were recorded on days between 1st and 14th days following the gingivectomies
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 15 Feb 2018.
- Background: PubMed 19485829Giannelli M, Bani D, Tani A, Pini A, Margheri M, Zecchi-Orlandini S, Tonelli P, Formigli L. In vitro evaluation of the effects of low-intensity Nd:YAG laser irradiation on the inflammatory reaction elicited by bacterial lipopolysaccharide adherent to titanium dental implants. J Periodontol. 2009 Jun;80(6):977-84. doi: 10.1902/jop.2009.080648.
- Background: PubMed 16579711Tomasi C, Schander K, Dahlen G, Wennstrom JL. Short-term clinical and microbiologic effects of pocket debridement with an Er:YAG laser during periodontal maintenance. J Periodontol. 2006 Jan;77(1):111-8. doi: 10.1902/jop.2006.77.1.111.
- Background: PubMed 26360009Favia G, Tempesta A, Limongelli L, Suppressa P, Sabba C, Maiorano E. Diode laser treatment and clinical management of multiple oral lesions in patients with hereditary haemorrhagic telangiectasia. Br J Oral Maxillofac Surg. 2016 May;54(4):379-83. doi: 10.1016/j.bjoms.2015.08.260. Epub 2015 Sep 8.
- Individual participant dataSharing planned: No
Related trials for Gingival Overgrowth
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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.
Ahu Uraz, PhD Dr study director
Gazi University
Questions about this trial
What is this clinical trial studying?
A study testing Ceramic rotary bur, Diode laser and Scalpel in people with Gingival Overgrowth, run by T.C. Dumlupınar Üniversitesi.
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 7 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 15 Feb 2018. 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?
Postoperative wound healing change (time frame: The wound surface areas of foamy fields on the all of the groups' photographs were recorded change between 1st day and 14th day following the gingivectomies.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03435068, which also lists 3 linked publications.
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 15 Feb 2018.