Gingival OvergrowthPhase 2NCT06806319
Assessment of Growth Factors Levels Associated with Wound Healing After Soft Tissue Crown Lengthening
A Phase 2 study testing single intervention by Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μm and single intervention by electrosurgical unit which was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%. in people with Gingival Overgrowth, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Clinicians often encounter the need for crown lengthening in the practice of dentistry and have to make treatment decisions taking into consideration how to best address the biological, functional, and esthetic requirements of each particular case. The concept of crown lengthening was first introduced by D.W. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Gingival Overgrowth
- What is being tested?
- single intervention by Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μm and single intervention by electrosurgical unit which was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Oct 2021to 27 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Men and women aged ≥ 18 years. 2. Patients with short clinical crowns to enhance esthetic, exposure of subgingival caries for prosthetic replacement, exposure of a fracture or combination. 3. All patients were free from any systemic diseases according to the criteria of Modified Cornell Medical Index. 4. All patients need soft tissue removal and don't need osseous resection. 5. Full-Mouth Plaque Score (FMPS) ≤ 20% at baseline. 6. Full-Mouth Bleeding Score (FMBS) ≤ 20% at baseline.
Who cannot join
- 1. Light smokers i.e. smoking > 10 cigarettes/day. 2. Patients with medical conditions contraindicating surgical interventions. 3. Pregnancy or lactation. 4. Patients with active periodontal disease (PD ≥ 6 mm) 5. Clinical and/or radiographic signs of periapical pathology. 6. Patients with pacemakers.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dental medicine, Al-Azhar University (Assiut branch)
Asyut, Asyut Governorate, 71524
About this study
Official title: Soft Tissue Crown Lengthening and Attached Gingiva Remodeling: Assessment of Growth Factors Levels Associated with Wound Healing
Clinicians often encounter the need for crown lengthening in the practice of dentistry and have to make treatment decisions taking into consideration how to best address the biological, functional, and esthetic requirements of each particular case. The concept of crown lengthening was first introduced by D.W. Cohen (1962) and is presently a procedure that often employs some combination of tissue reduction or removal , osseous surgery , and/or orthodontics for tooth exposure and increasing the extent of supra gingival tooth structure for restoration of aesthetic purposes . Gingivectomy and gingivoplasty considered kind of crown lengthening procedure. Gingivectomy is defined as the excision of the soft tissue wall of a pocket. The procedure is usually combined with the recontouring of hyperplastic tissue by gingivectoplasty to restore physiological gingival form . Gingivoplasty is a reshaping of the gingiva to create physiologic gingival contours, with the sole purpose of recontouring the gingiva in the absence of pockets. In doing so, the complete anatomical crown becomes exposed and pseudo pockets are eliminated creating a better environment for periodontal health. Treatment options for crown lengthening procedures include: Surgical, Electrocautery or by Laser. The aim of the present study was to compare the practical effectiveness and postoperative parameters of using diode laser and electrocautery for crown lengthening procedure.
- Conditions
- Gingival Overgrowth
- Being tested
- single intervention by Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μm, single intervention by electrosurgical unit which was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%.
- Keywords
- Diode Laser, Electrosurgery, Crown Lengthening, Gingival crevicular fluid, Fibroblast Growth Factor, Platelet-Derived Growth Factor, Transforming Growth Factor beta1
- Medical subject headings
- Gingival Overgrowth, Hyperthermia, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single intervention by Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μmDevice
single intervention by Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μm.single intervention the follow-up until 6 months
single intervention by electrosurgical unit which was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%.Device
single intervention by electrosurgical unit which was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%.single intervention then follow-up until 6 months
| Study group | Role | What they receive |
|---|---|---|
| Laser crown lengthening technique | Active comparator | 1-The patients were anesthetized using infiltration technique and/ or nerve block. 2-Specific protective glasses were used for patient, dentist, and assistant. Highly reflective instruments or instruments with mirrored surface were voided as there could be reflection of the laser beam. 3- The pocket depths in the surgical site were measured. Dots made in the gingiva by using Krane Kaplen tweezer, then area to be cut outlined by connection of dots (fig.6(D)) using Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μm (fig.8). 4-Continue to split the dots halfway until there was a continuing line of dots by using the diode laser, 5-During the entire procedure, the tip was constantly checked for any debris of the ablated tissues and was cleaned with sterile moist gauze.6-Physiological gingival contour was achieved by changing the angulation of the tip as required during the procedure. 7-After the surgery, the end of the fiber (2-3mm) Receives: Device: single intervention by Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μm |
| Electrocautery crown lengthening | Active comparator | 1-Patients were anesthetized by infiltration technique and/ or nerve block 2-The pocket depths in the surgical site were measured using crane Kaplan tweezer. 3-Patient asked to hold the reusable silicone patient plate. 4-The output power of electrosurgical unit (fig.6) was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%. 5-Continue to split the dots halfway until there was a continuing line of dots. 6-Avoid the operation of equipment in a room with flammable or explosive materials. 7-Rapid, well-planned movements without pressure and it should be like brushing strokes keep electrode moving all the time, use high enough current. 8-A cooling period of 8 seconds should be allowed between successive incisions with the electrode. 9-Continuous saline irrigation was given while using the electrocautery. 10-The excised tissues are removed with Orban knife. Receives: Device: single intervention by electrosurgical unit which was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelization rate
After gingivectomy operation, the surgical site was evaluated with hydrogen peroxide to detect the presence of epithelization. The mesio-distal width of the maxillary right central tooth was recorded for each patient, and photographs were calibrated via the reference values. all photographs were examined with the assistance of Image processing and analysis in Java, Image J software. In the areas subjected to hydrogen peroxide application and experiencing tissue reaction, there was a lack of an epithelial layer in the wound area.
Measured: From enrollment to the end of treatment at 3 weeks
Transforming Growth Factor-β1 (TGF-β1) levels assessment
The levels of TGF-β1 in the GCF samples were determined using commercially available ELISA Kits
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start3 Oct 2021
- Primary completion20 Jun 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gingival OvergrowthStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asem Mohammed Kamel Ali, Al-Azhar University
- Investigators
- Asem M lecturer, PhD, Principal investigator, Faculty of Dental Medicine, Al-Azhar University (Assiut branch)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806319
- Sponsor's protocol ID
- crown lengthening and gingiva
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeballos BK, Rubina YN, Meza-Mauricio J, Cafferata EA, Vergara-Buenaventura A. Laser gingivectomy for maintaining periodontal health in fixed orthodontic patients: a systematic review. Lasers in Dental Science. 2024 Dec;8(1):1-5.
Mehrotra S, Ahuja A, Chowdhary Z, Adhupia KS, Bajaj A, Loitongbam M. Evaluation of the Effect of Diode Laser on Healing after Gingivectomy. Pesquisa Brasileira em Odontopediatria e Clínica Integrada. 2025 Jan 15;25:e230116-.
Rakmanee T, Calciolari E, Olsen I, Darbar U, Griffiths GS, Petrie A, Donos N. Expression of growth mediators in the gingival crevicular fluid of patients with aggressive periodontitis undergoing periodontal surgery. Clin Oral Investig. 2019 Aug;23(8):3307-3318. doi: 10.1007/s00784-018-2752-z. Epub 2018 Nov 29.
PubMed 30498980Kuru L, Yilmaz S, Kuru B, Kose KN, Noyan U. Expression of growth factors in the gingival crevice fluid of patients with phenytoin-induced gingival enlargement. Arch Oral Biol. 2004 Nov;49(11):945-50. doi: 10.1016/j.archoralbio.2004.04.010.
PubMed 15353252Guler B, Isler SC, Uraz A, Bozkaya S, Cetiner FD. The comparison of postoperative wound healing following different gingivectomy techniques: A randomized prospective clinical trial.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Crown Lengthening and Attached Gingiva Remodeling: Assessment of Growth Factors Levels Associated with Wound Healing
- ClinicalTrials.gov ID
- NCT06806319
- Acronym / sponsor ID
- crown lengthening and gingiva
- Conditions
- Gingival Overgrowth
- Keywords
- Diode Laser, Electrosurgery, Crown Lengthening, Gingival crevicular fluid, Fibroblast Growth Factor, Platelet-Derived Growth Factor, Transforming Growth Factor beta1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 4 Feb 2025 (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.
Clinicians often encounter the need for crown lengthening in the practice of dentistry and have to make treatment decisions taking into consideration how to best address the biological, functional, and esthetic requirements of each particular case. The concept of crown lengthening was first introduced by D.W. Cohen (1962) and is presently a procedure that often employs some combination of tissue reduction or removal , osseous surgery , and/or orthodontics for tooth exposure and increasing the extent of supra gingival tooth structure for restoration of aesthetic purposes . Gingivectomy and gingivoplasty considered kind of crown lengthening procedure. Gingivectomy is defined as the excision of the soft tissue wall of a pocket. The procedure is usually combined with the recontouring of hyperplastic tissue by gingivectoplasty to restore physiological gingival form . Gingivoplasty is a reshaping of the gingiva to create physiologic gingival contours, with the sole purpose of recontouring the gingiva in the absence of pockets. In doing so, the complete anatomical crown becomes exposed and pseudo pockets are eliminated creating a better environment for periodontal health. Treatment options for crown lengthening procedures include: Surgical, Electrocautery or by Laser. The aim of the present study was to compare the practical effectiveness and postoperative parameters of using diode laser and electrocautery for crown lengthening procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser crown lengthening technique | Active comparator | Device: single intervention by Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μm1-The patients were anesthetized using infiltration technique and/ or nerve block. 2-Specific protective glasses were used for patient, dentist, and assistant. Highly reflective instruments or instruments with mirrored surface were voided as there could be reflection of the laser beam. 3- The pocket depths in the surgical site were measured. Dots made in the gingiva by using Krane Kaplen tweezer, then area to be cut outlined by connection of dots (fig.6(D)) using Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μm (fig.8). 4-Continue to split the dots halfway until there was a continuing line of dots by using the diode laser, 5-During the entire procedure, the tip was constantly checked for any debris of the ablated tissues and was cleaned with sterile moist gauze.6-Physiological gingival contour was achieved by changing the angulation of the tip as required during the procedure. 7-After the surgery, the end of the fiber (2-3mm) |
| Electrocautery crown lengthening | Active comparator | Device: single intervention by electrosurgical unit which was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%.1-Patients were anesthetized by infiltration technique and/ or nerve block 2-The pocket depths in the surgical site were measured using crane Kaplan tweezer. 3-Patient asked to hold the reusable silicone patient plate. 4-The output power of electrosurgical unit (fig.6) was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%. 5-Continue to split the dots halfway until there was a continuing line of dots. 6-Avoid the operation of equipment in a room with flammable or explosive materials. 7-Rapid, well-planned movements without pressure and it should be like brushing strokes keep electrode moving all the time, use high enough current. 8-A cooling period of 8 seconds should be allowed between successive incisions with the electrode. 9-Continuous saline irrigation was given while using the electrocautery. 10-The excised tissues are removed with Orban knife. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Men and women aged ≥ 18 years. 2. Patients with short clinical crowns to enhance esthetic, exposure of subgingival caries for prosthetic replacement, exposure of a fracture or combination. 3. All patients were free from any systemic diseases according to the criteria of Modified Cornell Medical Index. 4. All patients need soft tissue removal and don't need osseous resection. 5. Full-Mouth Plaque Score (FMPS) ≤ 20% at baseline. 6. Full-Mouth Bleeding Score (FMBS) ≤ 20% at baseline.
Key exclusion criteria (1 listed)
- 1. Light smokers i.e. smoking > 10 cigarettes/day. 2. Patients with medical conditions contraindicating surgical interventions. 3. Pregnancy or lactation. 4. Patients with active periodontal disease (PD ≥ 6 mm) 5. Clinical and/or radiographic signs of periapical pathology. 6. Patients with pacemakers.
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 |
|---|---|---|
| single intervention by Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μmsingle intervention by Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μm.single intervention the follow-up until 6 months | Device | Laser crown lengthening technique |
| single intervention by electrosurgical unit which was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%.single intervention by electrosurgical unit which was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%.single intervention then follow-up until 6 months | Device | Electrocautery crown lengthening |
Primary outcome
Epithelization rate
Time frame: From enrollment to the end of treatment at 3 weeks
After gingivectomy operation, the surgical site was evaluated with hydrogen peroxide to detect the presence of epithelization. The mesio-distal width of the maxillary right central tooth was recorded for each patient, and photographs were calibrated via the reference values. all photographs were examined with the assistance of Image processing and analysis in Java, Image J software. In the areas subjected to hydrogen peroxide application and experiencing tissue reaction, there was a lack of an epithelial layer in the wound area.
Transforming Growth Factor-β1 (TGF-β1) levels assessment
Time frame: From enrollment to the end of treatment at 8 weeks
The levels of TGF-β1 in the GCF samples were determined using commercially available ELISA Kits
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 4 Feb 2025.
- BackgroundZeballos BK, Rubina YN, Meza-Mauricio J, Cafferata EA, Vergara-Buenaventura A. Laser gingivectomy for maintaining periodontal health in fixed orthodontic patients: a systematic review. Lasers in Dental Science. 2024 Dec;8(1):1-5.
- BackgroundMehrotra S, Ahuja A, Chowdhary Z, Adhupia KS, Bajaj A, Loitongbam M. Evaluation of the Effect of Diode Laser on Healing after Gingivectomy. Pesquisa Brasileira em Odontopediatria e Clínica Integrada. 2025 Jan 15;25:e230116-.
- Background: PubMed 30498980Rakmanee T, Calciolari E, Olsen I, Darbar U, Griffiths GS, Petrie A, Donos N. Expression of growth mediators in the gingival crevicular fluid of patients with aggressive periodontitis undergoing periodontal surgery. Clin Oral Investig. 2019 Aug;23(8):3307-3318. doi: 10.1007/s00784-018-2752-z. Epub 2018 Nov 29.
- Background: PubMed 15353252Kuru L, Yilmaz S, Kuru B, Kose KN, Noyan U. Expression of growth factors in the gingival crevice fluid of patients with phenytoin-induced gingival enlargement. Arch Oral Biol. 2004 Nov;49(11):945-50. doi: 10.1016/j.archoralbio.2004.04.010.
- BackgroundGuler B, Isler SC, Uraz A, Bozkaya S, Cetiner FD. The comparison of postoperative wound healing following different gingivectomy techniques: A randomized prospective clinical trial.
- Individual participant dataSharing planned: No
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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.
Asem M lecturer, PhD principal investigator
Faculty of Dental Medicine, Al-Azhar University (Assiut branch)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing single intervention by Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μm and single intervention by electrosurgical unit which was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%. in people with Gingival Overgrowth, run by Al-Azhar University at 1 site in Egypt.
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 1 inclusion and 1 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 4 Feb 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 Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epithelization rate (time frame: From enrollment to the end of treatment at 3 weeks). 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 NCT06806319, which also lists 5 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 4 Feb 2025.