ClinicalTrials.gg
CompletedNCT03435068Updated Feb 15, 2018

Soft Tissue Wound Healing Following Different Gingivectomy Techniques

An interventional study of Ceramic rotary bur and Diode laser in Gingival Overgrowth, sponsored by T.C. Dumlupınar Üniversitesi. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-15.

Sponsored by T.C. Dumlupınar Üniversitesi · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Apr 2016, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Gingival Overgrowth

Browse trials for

Keywords

  • rotary
  • diode laser
  • gingivectomy
  • wound healing
03

In context

Gingival Overgrowth

18 studies on the registry are indexed under Gingival Overgrowth; 1 is open to participants now.

This study's enrollment of 45 is above the median of 30 across 17 interventional studies indexed under Gingival Overgrowth.

Browse Gingival Overgrowth studies →

Lead sponsor

T.C. Dumlupınar Üniversitesi is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Ceramic rotary bur

    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.

    Device: Ceramic rotary bur

  • Experimental
    Diode laser

    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.

    Device: Diode laser

  • Active comparator
    Scalpel

    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

    Device: Scalpel

Interventions

  • DeviceCeramic rotary bur

    Gingivoplasties were performed with the same ceramic burs to easily provide a knife-edge appearance with ceramic rotary bur

    Also known as: Meisenger ceramic rotary bur

  • DeviceDiode laser

    The fiber optic laser tip had a 320-μm diameter with a 2.8 W output power were used in the study.

    Also known as: SiroLase Advance &Xtend

  • DeviceScalpel

    Scalpel surgery were performed as control group (conventioanl group).

06

What researchers measure

Primary outcomes

  1. Postoperative wound healing change

    After gingivectomy operation, the surgical site was evaluated with hydrogen peroxide to detect the presence of epithelization

    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.

Secondary outcomes

  1. Postoperative pain

    The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms

    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

  2. Postoperative erythema

    The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms

    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

  3. Postoperative burning

    The Visual Analogue Scale is a 100-mm horizontal-line scale that is used to quantify subjective symptoms

    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

07

Study locations

No study locations are listed for this record.

08

References and documents

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 19485829 ↗
  • Tomasi 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 16579711 ↗
  • Favia 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2016 to primary completion in Sep 2017, 17 months.

Of 11 interventional studies with no phase under Gingival Overgrowth, half reached primary completion within 10 months of starting (the median); a quarter within 5 and three quarters within 17. This study's 17 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2018
First posted
Feb 15, 2018
StartActual
Apr 1, 2016
Primary completionActual
Sep 30, 2017
CompletionActual
Nov 30, 2017
Last update
Feb 15, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03435068
Lead sponsor
T.C. Dumlupınar Üniversitesi
Responsible party
Berceste Guler (Assist .Prof, T.C. Dumlupınar Üniversitesi) — Principal investigator
First posted
Feb 15, 2018
Start date
Apr 1, 2016
Primary completion
Sep 30, 2017
Completion
Nov 30, 2017
Last update
Feb 15, 2018

Study contacts

Ahu Uraz, PhD Dr
study director · Gazi University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion