Gingival EnlargementNCT06753305
The Effect of Ozone Therapy on Gingivoplasty
A study testing Gingivectomy and gingivoplasty surgery and periodontal paste +ozone therapy application and Gingivectomy and gingivoplasty surgery and periodontal paste application in people with Gingival Enlargement, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Ozone therapy after gingivectomy and gingivoplasty has been found to reduce patients' pain levels and positively impact their quality of life. This study aimed to compare the healing potential of the wound surface following gingivectomy and gingivoplasty surgery applied to the maxillary anterior regions with classical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Enlargement
- What is being tested?
- Gingivectomy and gingivoplasty surgery and periodontal paste +ozone therapy application and Gingivectomy and gingivoplasty surgery and periodontal paste application
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be over 18 years old
- Systemically healthy individuals
- Gingival enlargement due to inflammation in at least 4 teeth in the maxillary anterior region
- Horizontal and vertical gingival growth index score of 1 or 2
- Gingival thickness more than 2 mm
- Good oral hygiene
- No loss of clinical attachment
Who cannot join
- Pregnancy
- Hereditary gingival fibromatosis
- Drug-induced gingival enlargement
- Allergy
- Presence of systemic conditions requiring antibiotic prophylaxis
- Acute and untreated periodontitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kütahya Health Sciences University Faculty of Dentistry
Kütahya, 43100
Berceste Guler Ayyıldız, Assoc. Prof., 05518489820, seymek.91@gmail.com
Seyma Eken, Lect. Dr., 05518489820, seymek.91@gmail.com
About this study
Official title: Evaluation of the Effect of Ozone Therapy Application on Wound Healing After Gingivoplasty
Ozone therapy after gingivectomy and gingivoplasty has been found to reduce patients' pain levels and positively impact their quality of life. This study aimed to compare the healing potential of the wound surface following gingivectomy and gingivoplasty surgery applied to the maxillary anterior regions with classical periodontal paste application (Coe-pak) using activated oxygen (Cure 09 Active Oxygen) and classical periodontal paste application only (Coe-pak).
The study will include 48 systemically healthy patients older than 18 years of age with gingival enlargement in the maxillary anterior region, requiring gingivectomy and gingivoplasty surgery, who applied to Kütahya University of Health Sciences, Faculty of Dentistry, Department of Periodontology and Izmir Democracy University, Faculty of Dentistry, Department of Periodontology. Patients will be evaluated in two different groups as test and control group after surgery. Patients will be randomly divided into study groups by closed envelope method. The test group will receive periodontal paste (Coe-pak) + Ozone therapy (active oxygen (Cure 09 Active Oxygen)) after gingivectomy and gingivoplasty surgery, while the control group will receive only periodontal paste after gingivectomy and gingivoplasty surgery. All patients will undergo gingivectomy and gingivoplasty with the same procedure
Read the detailed description
Gingival enlargement leads to unaesthetic appearance, increased susceptibility to periodontal disease and halitosis by making it difficult to control plaque, and chewing and speech disorders by affecting functional function. Gingivectomy and gingivoplasty are used for the excision of diseased gingiva or gingival enlargement to create a natural anatomical form of the gingiva and improve aesthetics. After gingivectomy and gingivoplasty surgery, secondary healing occurs at the wound site. Bleeding and pain as a result of secondary healing negatively affect the patient's quality of life. Many different treatment methods such as ozone therapy, laser therapy, antiseptic agents, platelet concentrate, and herbal products are applied to reduce postoperative complications and increase patient comfort after gingivectomy and gingivoplasty. Since ozone gas increases growth factors, activates local antioxidant mechanisms, and supports tissue repair, its application to the wound site prevents postoperative infection and may accelerate wound healing. Topical application of ozone gas has been reported to be effective in the early stages of wound healing by increasing the amount of vascular endothelial growth factor expression. In a systematic review aiming to evaluate the effectiveness of ozone therapy in reducing the symptoms of oral diseases, especially oral mucositis, which is a serious complication of cancer treatment, it was confirmed that ozone has analgesic, anti-inflammatory, antimicrobial, and regenerative properties. In a study, it was found that the application of ozone therapy after gingivectomy and gingivoplasty reduced the pain levels of patients and positively affected their quality of life. To compare the healing potential of the wound surface following gingivectomy and gingivoplasty surgery applied to the maxillary anterior regions with the application of classical periodontal paste (Coe-pak) using activated oxygen (Cure 09 Active Oxygen) and with the application of classical periodontal paste (Coe-pak) alone.
The study will include 48 systemically healthy, systemically healthy patients older than 18 years of age, with gingival enlargement in the maxillary anterior region, requiring gingivectomy and gingivoplasty surgery, who applied to Kütahya University of Health Sciences, Faculty of Dentistry, Department of Periodontology and İzmir Democracy University, Faculty of Dentistry, Department of Periodontology. All patients will be called for re-evaluation 4 weeks after phase 1 periodontal treatment and surgical treatment will be planned. Clinical measurements (plaque index, gingival index, pocket depth, bleeding index on probing, and gingival overgrowth index) and oral health impact profile-14 questionnaire will be recorded and standard photographs will be taken before surgery. After local anesthesia, the incision line will be determined with a marking press or periodontal probe according to the amount of gingival enlargement. An external beveled incision will be made along the determined incision line with a No. 15 scalpel. Once the incision is complete, the surrounding tissues will be cleaned using microsurgical scissors. Following this, gingivoplasty will be performed. Patients will be randomly assigned to either the test group or the control group. In the test group, periodontal paste (Coe-Pak) will be applied to the area designated for secondary healing after ozone therapy (Cure 09 Active Oxygen). In the control group, only periodontal paste (Coe-Pak) will be applied. Postoperatively, the patient will record the bleeding status, daily analgesic use, and pain and burning with a visual analog scale for the first 7 days. Standard photographs will be taken in the postoperative period, immediately after the placement of the patch and on the 7th, 14th and 21st days. In addition, clinical evaluations (healing index, inflammation, modified manchester scar scale, surgical Area Plaque index, re-epithelialisation evaluation, and only on the 7th day, plaque accumulation in the periodontal paste) will be recorded from the patients on the 7th, 14th, and 21st days.
- Conditions
- Gingival Enlargement
- Being tested
- Gingivectomy and gingivoplasty surgery and periodontal paste +ozone therapy application, Gingivectomy and gingivoplasty surgery and periodontal paste application
- Keywords
- Gingival enlargement, Ozone therapy, Wound healing, Gingivectomy, Gingivoplasty
- Medical subject headings
- Gingival Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingivectomy and gingivoplasty surgery and periodontal paste +ozone therapy applicationProcedure or surgery
After taking systemic and dental anamnesis from all patients, Phase 1 periodontal treatment will be performed and oral hygiene education will be given. Patients will be called 4 weeks after treatment for re-evaluation and surgical treatment will be planned. After local anesthesia, the incision line will be determined with a marking press or periodontal probe according to the amount of gingival enlargement. An external bevel incision will be made along the determined incision line with a number 15 scalpel. After the incision is completed, the remaining tissues will be removed using microsurgical scissors. Then gingivoplasty will be performed. After gingivectomy and gingivoplasty, the surgical site will be left for secondary healing. Periodontal paste (Coe-pak) will be applied to the area left for secondary healing after ozone therapy (activated oxygen (Cure 09 Active Oxygen))
Gingivectomy and gingivoplasty surgery and periodontal paste applicationProcedure or surgery
After taking systemic and dental anamnesis from all patients, Phase 1 periodontal treatment will be performed and oral hygiene education will be given. Patients will be called 4 weeks after treatment for re-evaluation and surgical treatment will be planned. After local anesthesia, the incision line will be determined with a marking press or periodontal probe according to the amount of gingival enlargement. An external bevel incision will be made along the determined incision line with a number 15 scalpel. After the incision is completed, the remaining tissues will be removed using microsurgical scissors. Then gingivoplasty will be performed. After gingivectomy and gingivoplasty, the surgical site will be left for secondary healing. Only periodontal paste will be applied after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Other | Periodontal paste application (Coe-pak) using active oxygen (Cure 09 Active Oxygen) on the wound surface after gingivectomy and gingivoplasty surgery applied to the maxillary anterior regions Receives: Procedure: Gingivectomy and gingivoplasty surgery and periodontal paste +ozone therapy application |
| Control group | Other | Only periodontal paste application (Coe-pak) to the wound surface after gingivectomy and gingivoplasty surgery applied to the maxillary anterior regions Receives: Procedure: Gingivectomy and gingivoplasty surgery and periodontal paste application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival inflammation
The effect of ozone therapy on inflammation will be measured in the 1-month follow-up after gingivectomy and gingivoplasty surgery.
Inflammation 0=no inflammation,
- mild inflammation,
- moderate inflammation,
- severe inflammation
Measured: 1-month follow-up after gingivectomy and gingivoplasty surgery
Gingival contour
The effect of ozone therapy on gingival contour after gingivectomy and gingivoplasty surgery was measured using the Modified Manchester Scar Scale at 1-month follow-up.
Modified Manchester Scar Scale (used to assess gingival colour, contour, and distortion) The colour of the wound compared to the adjacent mucosa score 0= perfect fit score 1= slight non-compliance score 2= obvious incompatibility The contour of the wound compared to the surrounding tissues score 0= similar score 1= slightly raised or indented score 2= hypertrophic Wound distortion score 0= no distortion score 1= slight distortion score 2= obvious distortion The total of the scores in the three categories indicates the wound healing score, the total score ranges from 0 to 6, with lower scores indicating better healing.
Measured: 1-month follow-up after gingivectomy and gingiplasty
Re-epithelialisation evaluation
To measure the effect of ozone therapy on re-epithelialization after gingivectomy and gingivoplasty surgeries with toluidine blue or 3% H2O2 intraoral photographs at 1-month follow-up.
Measured: 1-month follow-up after gingivectomy and gingivoplasty surgery
Gingival distortion
To measure the effect of ozone therapy on gingival distorrion via Modified Manchester Scar Scale after gingivectomy and gingivoplasty surgery at 1-month follow-up.
Modified Manchester Scar Scale (used to assess gingival colour, contour, and distortion) The colour of the wound compared to the adjacent mucosa score 0= perfect fit score 1= slight non-compliance score 2= obvious incompatibility The contour of the wound compared to the surrounding tissues score 0= similar score 1= slightly raised or indented score 2= hypertrophic Wound distortion score 0= no distortion score 1= slight distortion score 2= obvious distortion The total of the scores in the three categories indicates the wound healing score, the total score ranges from 0 to 6, with lower scores indicating better healing.
Measured: 1-month follow-up after gingivectomy and gingiplasty
Secondary outcomes (1)
Patient's quality of life
The effect of ozone therapy on wound healing after gingivectomy and gingivoplasty surgery will be measured at 1-month follow-up using a visual analog scale on patient quality of life.
Measured: 1-month follow-up after gingivectomy and gingiplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start15 Nov 2022
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gingival EnlargementStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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 study will include 48 systemically healthy, systemically healthy patients older than 18 years of age, with gingival enlargement in the maxillary anterior region, requiring gingivectomy and gingivoplasty surgery, who applied to Kütahya University of Health Sciences, Faculty of Dentistry, Department of Periodontology and İzmir Democracy University, Faculty of Dentistry, Department of Periodontology. Patients will be evaluated in two different groups as test and control group after surgery. Patients will be randomly allocated to the study groups by closed envelope method. The test group will receive periodontal paste (Coe-pak) + Ozone therapy (activated oxygen (Cure 09 Active Oxygen)) following gingivectomy and gingivoplasty surgery, while the control group will receive only periodontal paste application following gingivectomy and gingivoplasty surgery. All patients will undergo gingivectomy and gingivoplasty with the same procedure.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berceste Guler, Kutahya Health Sciences University
- Investigators
- Berceste Güler Ayyıldız, Assoc. Prof., Study director, Kütahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753305
- Sponsor's protocol ID
- 2022-15/01
- Status last verified
- Sep 2025
- First submitted
- 27 Nov 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Statistical Analysis Plan (SAP)
Publications
Uslu MO, Akgul S. Evaluation of the effects of photobiomodulation therapy and ozone applications after gingivectomy and gingivoplasty on postoperative pain and patients' oral health-related quality of life. Lasers Med Sci. 2020 Sep;35(7):1637-1647. doi: 10.1007/s10103-020-03037-8. Epub 2020 May 20.
PubMed 32435906Gupta G, Mansi B. Ozone therapy in periodontics. J Med Life. 2012 Feb 22;5(1):59-67. Epub 2012 Mar 5.
PubMed 22574088Eroglu ZT, Kurtis B, Altug HA, Sahin S, Tuter G, Baris E. Effect of topical ozonetherapy on gingival wound healing in pigs: histological and immuno-histochemical analysis. J Appl Oral Sci. 2018 Dec 10;27:e20180015. doi: 10.1590/1678-7757-2018-0015.
PubMed 30540068Chesterman J, Beaumont J, Kellett M, Durey K. Gingival overgrowth: Part 2: management strategies. Br Dent J. 2017 Feb 10;222(3):159-165. doi: 10.1038/sj.bdj.2017.111.
PubMed 28184072Bozkurt E, Uslu MO. Evaluation of the effects of platelet-rich fibrin, concentrated growth factors, and autologous fibrin glue application on wound healing following gingivectomy and gingivoplasty operations: a randomized controlled clinical trial. Quintessence Int. 2022 Mar 14;53(4):328-341. doi: 10.3290/j.qi.b2449819.
PubMed 34927405Kusakci-Seker B, Demirayak-Akdemir M. The effect of non-thermal atmospheric pressure plasma application on wound healing after gingivectomy. Int Wound J. 2020 Oct;17(5):1376-1383. doi: 10.1111/iwj.13379. Epub 2020 May 27.
PubMed 32462820Beaumont J, Chesterman J, Kellett M, Durey K. Gingival overgrowth: Part 1: aetiology and clinical diagnosis. Br Dent J. 2017 Jan 27;222(2):85-91. doi: 10.1038/sj.bdj.2017.71.
PubMed 28127024
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Ozone Therapy Application on Wound Healing After Gingivoplasty
- ClinicalTrials.gov ID
- NCT06753305
- Acronym / sponsor ID
- 2022-15/01
- Conditions
- Gingival Enlargement
- Keywords
- Gingival enlargement, Ozone therapy, Wound healing, Gingivectomy, Gingivoplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 31 Dec 2024 (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.
Ozone therapy after gingivectomy and gingivoplasty has been found to reduce patients' pain levels and positively impact their quality of life. This study aimed to compare the healing potential of the wound surface following gingivectomy and gingivoplasty surgery applied to the maxillary anterior regions with classical periodontal paste application (Coe-pak) using activated oxygen (Cure 09 Active Oxygen) and classical periodontal paste application only (Coe-pak).
The study will include 48 systemically healthy patients older than 18 years of age with gingival enlargement in the maxillary anterior region, requiring gingivectomy and gingivoplasty surgery, who applied to Kütahya University of Health Sciences, Faculty of Dentistry, Department of Periodontology and Izmir Democracy University, Faculty of Dentistry, Department of Periodontology. Patients will be evaluated in two different groups as test and control group after surgery. Patients will be randomly divided into study groups by closed envelope method. The test group will receive periodontal paste (Coe-pak) + Ozone therapy (active oxygen (Cure 09 Active Oxygen)) after gingivectomy and gingivoplasty surgery, while the control group will receive only periodontal paste after gingivectomy and gingivoplasty surgery. All patients will undergo gingivectomy and gingivoplasty with the same procedure
Detailed description
Gingival enlargement leads to unaesthetic appearance, increased susceptibility to periodontal disease and halitosis by making it difficult to control plaque, and chewing and speech disorders by affecting functional function. Gingivectomy and gingivoplasty are used for the excision of diseased gingiva or gingival enlargement to create a natural anatomical form of the gingiva and improve aesthetics. After gingivectomy and gingivoplasty surgery, secondary healing occurs at the wound site. Bleeding and pain as a result of secondary healing negatively affect the patient's quality of life. Many different treatment methods such as ozone therapy, laser therapy, antiseptic agents, platelet concentrate, and herbal products are applied to reduce postoperative complications and increase patient comfort after gingivectomy and gingivoplasty. Since ozone gas increases growth factors, activates local antioxidant mechanisms, and supports tissue repair, its application to the wound site prevents postoperative infection and may accelerate wound healing. Topical application of ozone gas has been reported to be effective in the early stages of wound healing by increasing the amount of vascular endothelial growth factor expression. In a systematic review aiming to evaluate the effectiveness of ozone therapy in reducing the symptoms of oral diseases, especially oral mucositis, which is a serious complication of cancer treatment, it was confirmed that ozone has analgesic, anti-inflammatory, antimicrobial, and regenerative properties. In a study, it was found that the application of ozone therapy after gingivectomy and gingivoplasty reduced the pain levels of patients and positively affected their quality of life. To compare the healing potential of the wound surface following gingivectomy and gingivoplasty surgery applied to the maxillary anterior regions with the application of classical periodontal paste (Coe-pak) using activated oxygen (Cure 09 Active Oxygen) and with the application of classical periodontal paste (Coe-pak) alone.
The study will include 48 systemically healthy, systemically healthy patients older than 18 years of age, with gingival enlargement in the maxillary anterior region, requiring gingivectomy and gingivoplasty surgery, who applied to Kütahya University of Health Sciences, Faculty of Dentistry, Department of Periodontology and İzmir Democracy University, Faculty of Dentistry, Department of Periodontology. All patients will be called for re-evaluation 4 weeks after phase 1 periodontal treatment and surgical treatment will be planned. Clinical measurements (plaque index, gingival index, pocket depth, bleeding index on probing, and gingival overgrowth index) and oral health impact profile-14 questionnaire will be recorded and standard photographs will be taken before surgery. After local anesthesia, the incision line will be determined with a marking press or periodontal probe according to the amount of gingival enlargement. An external beveled incision will be made along the determined incision line with a No. 15 scalpel. Once the incision is complete, the surrounding tissues will be cleaned using microsurgical scissors. Following this, gingivoplasty will be performed. Patients will be randomly assigned to either the test group or the control group. In the test group, periodontal paste (Coe-Pak) will be applied to the area designated for secondary healing after ozone therapy (Cure 09 Active Oxygen). In the control group, only periodontal paste (Coe-Pak) will be applied. Postoperatively, the patient will record the bleeding status, daily analgesic use, and pain and burning with a visual analog scale for the first 7 days. Standard photographs will be taken in the postoperative period, immediately after the placement of the patch and on the 7th, 14th and 21st days. In addition, clinical evaluations (healing index, inflammation, modified manchester scar scale, surgical Area Plaque index, re-epithelialisation evaluation, and only on the 7th day, plaque accumulation in the periodontal paste) will be recorded from the patients on the 7th, 14th, and 21st days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will include 48 systemically healthy, systemically healthy patients older than 18 years of age, with gingival enlargement in the maxillary anterior region, requiring gingivectomy and gingivoplasty surgery, who applied to Kütahya University of Health Sciences, Faculty of Dentistry, Department of Periodontology and İzmir Democracy University, Faculty of Dentistry, Department of Periodontology. Patients will be evaluated in two different groups as test and control group after surgery. Patients will be randomly allocated to the study groups by closed envelope method. The test group will receive periodontal paste (Coe-pak) + Ozone therapy (activated oxygen (Cure 09 Active Oxygen)) following gingivectomy and gingivoplasty surgery, while the control group will receive only periodontal paste application following gingivectomy and gingivoplasty surgery. All patients will undergo gingivectomy and gingivoplasty with the same procedure.
| Arm | Type | Receives |
|---|---|---|
| Test group | Other | Procedure: Gingivectomy and gingivoplasty surgery and periodontal paste +ozone therapy applicationPeriodontal paste application (Coe-pak) using active oxygen (Cure 09 Active Oxygen) on the wound surface after gingivectomy and gingivoplasty surgery applied to the maxillary anterior regions |
| Control group | Other | Procedure: Gingivectomy and gingivoplasty surgery and periodontal paste applicationOnly periodontal paste application (Coe-pak) to the wound surface after gingivectomy and gingivoplasty surgery applied to the maxillary anterior regions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- be over 18 years old
- Systemically healthy individuals
- Gingival enlargement due to inflammation in at least 4 teeth in the maxillary anterior region
- Horizontal and vertical gingival growth index score of 1 or 2
- Gingival thickness more than 2 mm
Key exclusion criteria (6 listed)
- Pregnancy
- Hereditary gingival fibromatosis
- Drug-induced gingival enlargement
- Allergy
- Presence of systemic conditions requiring antibiotic prophylaxis
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 |
|---|---|---|
| Gingivectomy and gingivoplasty surgery and periodontal paste +ozone therapy applicationAfter taking systemic and dental anamnesis from all patients, Phase 1 periodontal treatment will be performed and oral hygiene education will be given. Patients will be called 4 weeks after treatment for re-evaluation and surgical treatment will be planned. After local anesthesia, the incision line will be determined with a marking press or periodontal probe according to the amount of gingival enlargement. An external bevel incision will be made along the determined incision line with a number 15 scalpel. After the incision is completed, the remaining tissues will be removed using microsurgical scissors. Then gingivoplasty will be performed. After gingivectomy and gingivoplasty, the surgical site will be left for secondary healing. Periodontal paste (Coe-pak) will be applied to the area left for secondary healing after ozone therapy (activated oxygen (Cure 09 Active Oxygen)) | Procedure or surgery | Test group |
| Gingivectomy and gingivoplasty surgery and periodontal paste applicationAfter taking systemic and dental anamnesis from all patients, Phase 1 periodontal treatment will be performed and oral hygiene education will be given. Patients will be called 4 weeks after treatment for re-evaluation and surgical treatment will be planned. After local anesthesia, the incision line will be determined with a marking press or periodontal probe according to the amount of gingival enlargement. An external bevel incision will be made along the determined incision line with a number 15 scalpel. After the incision is completed, the remaining tissues will be removed using microsurgical scissors. Then gingivoplasty will be performed. After gingivectomy and gingivoplasty, the surgical site will be left for secondary healing. Only periodontal paste will be applied after the surgery. | Procedure or surgery | Control group |
Primary outcome
Gingival inflammation
Time frame: 1-month follow-up after gingivectomy and gingivoplasty surgery
The effect of ozone therapy on inflammation will be measured in the 1-month follow-up after gingivectomy and gingivoplasty surgery. Inflammation 0=no inflammation, 1. mild inflammation, 2. moderate inflammation, 3. severe inflammation
Gingival contour
Time frame: 1-month follow-up after gingivectomy and gingiplasty
The effect of ozone therapy on gingival contour after gingivectomy and gingivoplasty surgery was measured using the Modified Manchester Scar Scale at 1-month follow-up. Modified Manchester Scar Scale (used to assess gingival colour, contour, and distortion) The colour of the wound compared to the adjacent mucosa score 0= perfect fit score 1= slight non-compliance score 2= obvious incompatibility The contour of the wound compared to the surrounding tissues score 0= similar score 1= slightly raised or indented score 2= hypertrophic Wound distortion score 0= no distortion score 1= slight distortion score 2= obvious distortion The total of the scores in the three categories indicates the wound healing score, the total score ranges from 0 to 6, with lower scores indicating better healing.
Re-epithelialisation evaluation
Time frame: 1-month follow-up after gingivectomy and gingivoplasty surgery
To measure the effect of ozone therapy on re-epithelialization after gingivectomy and gingivoplasty surgeries with toluidine blue or 3% H2O2 intraoral photographs at 1-month follow-up.
Gingival distortion
Time frame: 1-month follow-up after gingivectomy and gingiplasty
To measure the effect of ozone therapy on gingival distorrion via Modified Manchester Scar Scale after gingivectomy and gingivoplasty surgery at 1-month follow-up. Modified Manchester Scar Scale (used to assess gingival colour, contour, and distortion) The colour of the wound compared to the adjacent mucosa score 0= perfect fit score 1= slight non-compliance score 2= obvious incompatibility The contour of the wound compared to the surrounding tissues score 0= similar score 1= slightly raised or indented score 2= hypertrophic Wound distortion score 0= no distortion score 1= slight distortion score 2= obvious distortion The total of the scores in the three categories indicates the wound healing score, the total score ranges from 0 to 6, with lower scores indicating better healing.
1 secondary outcome
Patient's quality of life
Time frame: 1-month follow-up after gingivectomy and gingiplasty
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publication: PubMed 32435906Uslu MO, Akgul S. Evaluation of the effects of photobiomodulation therapy and ozone applications after gingivectomy and gingivoplasty on postoperative pain and patients' oral health-related quality of life. Lasers Med Sci. 2020 Sep;35(7):1637-1647. doi: 10.1007/s10103-020-03037-8. Epub 2020 May 20.
- Results publication: PubMed 22574088Gupta G, Mansi B. Ozone therapy in periodontics. J Med Life. 2012 Feb 22;5(1):59-67. Epub 2012 Mar 5.
- Results publication: PubMed 30540068Eroglu ZT, Kurtis B, Altug HA, Sahin S, Tuter G, Baris E. Effect of topical ozonetherapy on gingival wound healing in pigs: histological and immuno-histochemical analysis. J Appl Oral Sci. 2018 Dec 10;27:e20180015. doi: 10.1590/1678-7757-2018-0015.
- Results publication: PubMed 28184072Chesterman J, Beaumont J, Kellett M, Durey K. Gingival overgrowth: Part 2: management strategies. Br Dent J. 2017 Feb 10;222(3):159-165. doi: 10.1038/sj.bdj.2017.111.
- Results publication: PubMed 34927405Bozkurt E, Uslu MO. Evaluation of the effects of platelet-rich fibrin, concentrated growth factors, and autologous fibrin glue application on wound healing following gingivectomy and gingivoplasty operations: a randomized controlled clinical trial. Quintessence Int. 2022 Mar 14;53(4):328-341. doi: 10.3290/j.qi.b2449819.
- Results publication: PubMed 32462820Kusakci-Seker B, Demirayak-Akdemir M. The effect of non-thermal atmospheric pressure plasma application on wound healing after gingivectomy. Int Wound J. 2020 Oct;17(5):1376-1383. doi: 10.1111/iwj.13379. Epub 2020 May 27.
- Results publication: PubMed 28127024Beaumont J, Chesterman J, Kellett M, Durey K. Gingival overgrowth: Part 1: aetiology and clinical diagnosis. Br Dent J. 2017 Jan 27;222(2):85-91. doi: 10.1038/sj.bdj.2017.71.
- Individual participant dataSharing planned: Yes. Study Protocol Statistical Analysis Plan (SAP)
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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.
Berceste Güler Ayyıldız, Assoc. Prof. study director
Kütahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gingivectomy and gingivoplasty surgery and periodontal paste +ozone therapy application and Gingivectomy and gingivoplasty surgery and periodontal paste application in people with Gingival Enlargement, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 6 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: looking for participants now, as of the sponsor's last update on 5 Sep 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Berceste Güler Ayyıldız (+05059359207, berceste.guler@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival inflammation (time frame: 1-month follow-up after gingivectomy and gingivoplasty surgery). The study lists 4 primary outcomes in all. 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 NCT06753305, which also lists 7 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 5 Sep 2025.