Chronic Inflammatory Gingival EnlargementOZONE-GINGNCT07517328
Wound Healing After Gingivectomy
A study testing Gaseous ozone application and Gingivectomy/gingivoplasty in people with Chronic Inflammatory Gingival Enlargement and Gingival Enlargement, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Gingival enlargement caused by chronic inflammation may require surgical intervention when non-surgical periodontal therapy is insufficient. Gingivectomy and gingivoplasty are commonly performed procedures to remove excessive gingival tissue and restore normal gingival contour. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Chronic Inflammatory Gingival Enlargement, Gingival Enlargement, Gingival Hyperplasia
- What is being tested?
- Gaseous ozone application and Gingivectomy/gingivoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2016to 10 Mar 2026
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Systemically healthy individuals
- Patients diagnosed with chronic inflammatory gingival enlargement
- Presence of gingival enlargement affecting the maxillary or mandibular anterior region
- Symmetrical involvement of at least six teeth
- No clinical attachment loss
- Ability to maintain adequate oral hygiene following non-surgical periodontal therapy
- No pregnancy or lactation
Who cannot join
- Presence of systemic diseases that may affect wound healing
- Current orthodontic treatment
- Smoking or alcohol use
- Use of medications affecting periodontal tissues within the last two months
- Inability to maintain adequate oral hygiene
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Faculty of Dentistry, Department of Periodontology
Erzurum
About this study
Official title: The Effect of Adjunctive Gaseous Ozone Therapy on Wound Healing After Gingivectomy/Gingivoplasty in Patients With Chronic Inflammatory Gingival Enlargement: A Randomized Split-Mouth Clinical Trial
Gingival enlargement caused by chronic inflammation may require surgical intervention when non-surgical periodontal therapy is insufficient. Gingivectomy and gingivoplasty are commonly performed procedures to remove excessive gingival tissue and restore normal gingival contour. However, postoperative wound healing may be affected by factors such as microbial contamination and the inflammatory response.
Medical ozone therapy has antimicrobial, anti-inflammatory, and biostimulatory properties that may enhance tissue regeneration and accelerate wound healing. The aim of this randomized split-mouth clinical trial is to evaluate the effect of adjunctive gaseous ozone therapy on wound healing following gingivectomy/gingivoplasty in individuals with chronic inflammatory gingival enlargement.
Read more
Twenty-four systemically healthy participants diagnosed with chronic inflammatory gingival enlargement will be included. Surgical sites will be randomly assigned in a split-mouth design to either the test group (gingivectomy/gingivoplasty with adjunctive gaseous ozone application) or the control group (gingivectomy/gingivoplasty alone).
Clinical periodontal parameters (Plaque Index, Gingival Index, Bleeding on Probing, Probing Pocket Depth, and Clinical Attachment Level) will be assessed at baseline and post-operative Day 21. Histopathological outcomes (Superficial Cell Index and Keratinization Index) will be evaluated at baseline and on post-operative Days 1, 3, 7, and 21.
The results of this study are expected to provide clinical and histopathological evidence regarding the potential benefits of adjunctive ozone therapy in periodontal wound healing.
Read the detailed description
Chronic inflammatory gingival enlargement is a condition characterized by an increase in gingival volume due to inflammatory changes associated with dental plaque. Non-surgical periodontal therapy is the primary treatment approach; however, in some cases, surgical intervention such as gingivectomy or gingivoplasty is required to eliminate excess gingival tissue and restore gingival architecture.
Gingivectomy/gingivoplasty creates a surgical wound surface that is exposed to the oral environment and microbial flora. Therefore, the healing process may be influenced by several biological and environmental factors. Adjunctive therapeutic approaches that enhance wound healing and reduce microbial contamination may improve clinical outcomes following periodontal surgery.
Medical ozone therapy, consisting of a controlled mixture of oxygen (O₂) and ozone (O₃), has antimicrobial, anti-inflammatory, and immunomodulatory properties. It has also been suggested to stimulate fibroblast activity, enhance tissue oxygenation, and promote growth factor release, potentially accelerating tissue regeneration and wound healing.
The present study is designed as a single-center, randomized, split-mouth clinical trial with blinded outcome assessment to investigate the effect of adjunctive gaseous ozone therapy on wound healing following gingivectomy/gingivoplasty in patients with chronic inflammatory gingival enlargement.
A total of 24 systemically healthy individuals aged between 18 and 40 years diagnosed with chronic inflammatory gingival enlargement will be included. Following non-surgical periodontal therapy and oral hygiene instruction, gingivectomy/gingivoplasty will be performed under local anesthesia. Surgical sites will be randomly assigned using a coin-toss method in a split-mouth design to either the test group (gingivectomy/gingivoplasty with adjunctive gaseous ozone application) or the control group (gingivectomy/gingivoplasty alone).
In the test group, gaseous ozone will be applied to the surgical wound area using a dedicated probe for one minute per tooth according to the manufacturer's instructions. Ozone application will be repeated at 24 hours and on post-operative Day 3.
Clinical periodontal parameters (Plaque Index [PI], Gingival Index [GI], Bleeding on Probing [BOP], Probing Pocket Depth [PPD], and Clinical Attachment Level [CAL]) will be assessed at baseline and on post-operative Day 21.
Exfoliative cytology samples will be obtained from the wound area at baseline and on post-operative Days 1, 3, 7, and 21. Histopathological evaluation will be performed to determine the Superficial Cell Index (SCI) and Keratinization Index (KI), which are indicators of epithelial maturation and wound healing.
The findings of this study are expected to provide clinical and histopathological evidence regarding the potential benefits of adjunctive ozone therapy in periodontal wound healing and may support its use as an adjunctive treatment in periodontal surgical procedures.
- Being tested
- Gaseous ozone application, Gingivectomy/gingivoplasty
- Keywords
- Ozone Therapy, Gingivectomy, Wound Healing, Periodontal Surgery, Superficial Cell Index, Split-Mouth Clinical Trial
- Medical subject headings
- Gingival Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaseous ozone applicationProcedure or surgery
Gaseous ozone is applied to the surgical wound area using an ozone delivery probe for 1 minute per tooth following gingivectomy/gingivoplasty. The application is repeated at 24 hours and on post-operative Day 3.
Gingivectomy/gingivoplastyProcedure or surgery
Gingivectomy/gingivoplasty is performed under local anesthesia without any additional adjunctive treatment.
| Study group | Role | What they receive |
|---|---|---|
| Ozone Group | Experimental | Participants receive gingivectomy/gingivoplasty followed by adjunctive gaseous ozone application. Receives: Procedure: Gaseous ozone application; Procedure: Gingivectomy/gingivoplasty |
| Control Group | Active comparator | Participants receive gingivectomy/gingivoplasty without adjunctive ozone therapy. Receives: Procedure: Gingivectomy/gingivoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superficial Cell Index (SCI)
Evaluation of epithelial cell maturation and wound healing using exfoliative cytology based on the analysis of at least 200 cells per smear.
Measured: Baseline, and post-operative Days 1, 3, 7, and 21
Keratinization Index (KI)
Assessment of epithelial keratinization during the wound healing process using exfoliative cytology.
Measured: Baseline, and post-operative Days 1, 3, 7, and 21
Secondary outcomes (5)
Plaque Index (PI)
Measurement of dental plaque accumulation.
Measured: Baseline and post-operative Day 21
Gingival Index (GI)
Assessment of gingival inflammation severity.
Measured: Baseline and post-operative Day 21
Bleeding on Probing (BOP)
Evaluation of gingival bleeding following periodontal probing.
Measured: Baseline and post-operative Day 21
Probing Pocket Depth (PPD)
Measurement of periodontal pocket depth in millimeters.
Measured: Baseline and post-operative Day 21
Clinical Attachment Level (CAL)
Assessment of periodontal attachment level in millimeters.
Measured: Baseline and post-operative Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start5 May 2016
- Primary completion20 Feb 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Inflammatory Gingival EnlargementStudies 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
- This study uses a randomized split-mouth design. Surgical sites within the same participant are randomly assigned to either the test group (gingivectomy/gingivoplasty with adjunctive gaseous ozone application) or the control group (gingivectomy/gingivoplasty alone).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alparslan Dilsiz, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517328
- Sponsor's protocol ID
- ATAUNI-PERIO-OZONE-2026
- Other IDs
- BAP2018/6138
- Acronym
- OZONE-GING
- Status last verified
- Aug 2026
- First submitted
- 14 Mar 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to privacy and confidentiality concerns related to participant information. However, de-identified data may be made available from the corresponding author upon reasonable request for scientific purposes.
Publications
Abdul NS, Almughaiseeb AA, Alghannam SM, Alshaikh AB. Unlocking Healing: Ozone Therapy's Breakthrough in Oral Lesion Management - A Narrative Review. J Pharm Bioallied Sci. 2025 Jun;17(Suppl 2):S1076-S1079. doi: 10.4103/jpbs.jpbs_292_25. Epub 2025 Jun 18.
PubMed 40655745
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adjunctive Gaseous Ozone Therapy on Wound Healing After Gingivectomy/Gingivoplasty in Patients With Chronic Inflammatory Gingival Enlargement: A Randomized Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07517328
- Acronym / sponsor ID
- OZONE-GING / ATAUNI-PERIO-OZONE-2026
- Keywords
- Ozone Therapy, Gingivectomy, Wound Healing, Periodontal Surgery, Superficial Cell Index, Split-Mouth Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 5 May 2016 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 8 Apr 2026 (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.
Gingival enlargement caused by chronic inflammation may require surgical intervention when non-surgical periodontal therapy is insufficient. Gingivectomy and gingivoplasty are commonly performed procedures to remove excessive gingival tissue and restore normal gingival contour. However, postoperative wound healing may be affected by factors such as microbial contamination and the inflammatory response.
Medical ozone therapy has antimicrobial, anti-inflammatory, and biostimulatory properties that may enhance tissue regeneration and accelerate wound healing. The aim of this randomized split-mouth clinical trial is to evaluate the effect of adjunctive gaseous ozone therapy on wound healing following gingivectomy/gingivoplasty in individuals with chronic inflammatory gingival enlargement.
Twenty-four systemically healthy participants diagnosed with chronic inflammatory gingival enlargement will be included. Surgical sites will be randomly assigned in a split-mouth design to either the test group (gingivectomy/gingivoplasty with adjunctive gaseous ozone application) or the control group (gingivectomy/gingivoplasty alone).
Clinical periodontal parameters (Plaque Index, Gingival Index, Bleeding on Probing, Probing Pocket Depth, and Clinical Attachment Level) will be assessed at baseline and post-operative Day 21. Histopathological outcomes (Superficial Cell Index and Keratinization Index) will be evaluated at baseline and on post-operative Days 1, 3, 7, and 21.
The results of this study are expected to provide clinical and histopathological evidence regarding the potential benefits of adjunctive ozone therapy in periodontal wound healing.
Detailed description
Chronic inflammatory gingival enlargement is a condition characterized by an increase in gingival volume due to inflammatory changes associated with dental plaque. Non-surgical periodontal therapy is the primary treatment approach; however, in some cases, surgical intervention such as gingivectomy or gingivoplasty is required to eliminate excess gingival tissue and restore gingival architecture.
Gingivectomy/gingivoplasty creates a surgical wound surface that is exposed to the oral environment and microbial flora. Therefore, the healing process may be influenced by several biological and environmental factors. Adjunctive therapeutic approaches that enhance wound healing and reduce microbial contamination may improve clinical outcomes following periodontal surgery.
Medical ozone therapy, consisting of a controlled mixture of oxygen (O₂) and ozone (O₃), has antimicrobial, anti-inflammatory, and immunomodulatory properties. It has also been suggested to stimulate fibroblast activity, enhance tissue oxygenation, and promote growth factor release, potentially accelerating tissue regeneration and wound healing.
The present study is designed as a single-center, randomized, split-mouth clinical trial with blinded outcome assessment to investigate the effect of adjunctive gaseous ozone therapy on wound healing following gingivectomy/gingivoplasty in patients with chronic inflammatory gingival enlargement.
A total of 24 systemically healthy individuals aged between 18 and 40 years diagnosed with chronic inflammatory gingival enlargement will be included. Following non-surgical periodontal therapy and oral hygiene instruction, gingivectomy/gingivoplasty will be performed under local anesthesia. Surgical sites will be randomly assigned using a coin-toss method in a split-mouth design to either the test group (gingivectomy/gingivoplasty with adjunctive gaseous ozone application) or the control group (gingivectomy/gingivoplasty alone).
In the test group, gaseous ozone will be applied to the surgical wound area using a dedicated probe for one minute per tooth according to the manufacturer's instructions. Ozone application will be repeated at 24 hours and on post-operative Day 3.
Clinical periodontal parameters (Plaque Index [PI], Gingival Index [GI], Bleeding on Probing [BOP], Probing Pocket Depth [PPD], and Clinical Attachment Level [CAL]) will be assessed at baseline and on post-operative Day 21.
Exfoliative cytology samples will be obtained from the wound area at baseline and on post-operative Days 1, 3, 7, and 21. Histopathological evaluation will be performed to determine the Superficial Cell Index (SCI) and Keratinization Index (KI), which are indicators of epithelial maturation and wound healing.
The findings of this study are expected to provide clinical and histopathological evidence regarding the potential benefits of adjunctive ozone therapy in periodontal wound healing and may support its use as an adjunctive treatment in periodontal surgical procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a randomized split-mouth design. Surgical sites within the same participant are randomly assigned to either the test group (gingivectomy/gingivoplasty with adjunctive gaseous ozone application) or the control group (gingivectomy/gingivoplasty alone).
| Arm | Type | Receives |
|---|---|---|
| Ozone Group | Experimental | Procedure: Gaseous ozone application, Procedure: Gingivectomy/gingivoplastyParticipants receive gingivectomy/gingivoplasty followed by adjunctive gaseous ozone application. |
| Control Group | Active comparator | Procedure: Gingivectomy/gingivoplastyParticipants receive gingivectomy/gingivoplasty without adjunctive ozone therapy. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Systemically healthy individuals
- Patients diagnosed with chronic inflammatory gingival enlargement
- Presence of gingival enlargement affecting the maxillary or mandibular anterior region
- Symmetrical involvement of at least six teeth
- No clinical attachment loss
Key exclusion criteria (5 listed)
- Presence of systemic diseases that may affect wound healing
- Current orthodontic treatment
- Smoking or alcohol use
- Use of medications affecting periodontal tissues within the last two months
- Inability to maintain adequate oral hygiene
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 |
|---|---|---|
| Gaseous ozone applicationGaseous ozone is applied to the surgical wound area using an ozone delivery probe for 1 minute per tooth following gingivectomy/gingivoplasty. The application is repeated at 24 hours and on post-operative Day 3. | Procedure or surgery | Ozone Group |
| Gingivectomy/gingivoplastyGingivectomy/gingivoplasty is performed under local anesthesia without any additional adjunctive treatment. | Procedure or surgery | Control Group, Ozone Group |
Primary outcome
Superficial Cell Index (SCI)
Time frame: Baseline, and post-operative Days 1, 3, 7, and 21
Evaluation of epithelial cell maturation and wound healing using exfoliative cytology based on the analysis of at least 200 cells per smear.
Keratinization Index (KI)
Time frame: Baseline, and post-operative Days 1, 3, 7, and 21
Assessment of epithelial keratinization during the wound healing process using exfoliative cytology.
5 secondary outcomes
Plaque Index (PI)
Time frame: Baseline and post-operative Day 21
Gingival Index (GI)
Time frame: Baseline and post-operative Day 21
Bleeding on Probing (BOP)
Time frame: Baseline and post-operative Day 21
Probing Pocket Depth (PPD)
Time frame: Baseline and post-operative Day 21
Clinical Attachment Level (CAL)
Time frame: Baseline and post-operative Day 21
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 27 Aug 2026.
- Results publication: PubMed 40655745Abdul NS, Almughaiseeb AA, Alghannam SM, Alshaikh AB. Unlocking Healing: Ozone Therapy's Breakthrough in Oral Lesion Management - A Narrative Review. J Pharm Bioallied Sci. 2025 Jun;17(Suppl 2):S1076-S1079. doi: 10.4103/jpbs.jpbs_292_25. Epub 2025 Jun 18.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared due to privacy and confidentiality concerns related to participant information. However, de-identified data may be made available from the corresponding author upon reasonable request for scientific purposes.
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 study testing Gaseous ozone application and Gingivectomy/gingivoplasty in people with Chronic Inflammatory Gingival Enlargement and Gingival Enlargement, run by Ataturk 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 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 27 Aug 2026. 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?
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?
Superficial Cell Index (SCI) (time frame: Baseline, and post-operative Days 1, 3, 7, and 21). The study lists 2 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 NCT07517328, which also lists 1 linked publication.
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 27 Aug 2026.