High Frenum AttachmentPhase 4NCT06102642
The Clinical Usage of a Free Gingival Graft Combined With Frenotomy in Patients With High Frenal Attachment
A Phase 4 study testing Combining free gingival graft with frenotomy procedure in people with High Frenum Attachment and Free Gingival Graft, run by Cairo University.
Trial summary
In patients with high frenal attachment will placement of free gingival graft combined with frenotomy result in gain of width of keratinized gingiva, decrease relapse, improve mucosal healing and have acceptable postoperative pain? Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- High Frenum Attachment, Free Gingival Graft
- What is being tested?
- Combining free gingival graft with frenotomy procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Aug 2024
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-40 years old
- Systemically healthy
- Gingival and plaque index <10
- Good oral hygiene
- Highly attached mandibular labial frenum.
- Narrow sulcus depth
- Thin gingival phenotype
Who cannot join
- Smokers
- Poor oral hygiene
- Patient with a physical disability that hinders the upkeep of good oral hygiene measures.
- Taking any medications that could affect healing
- Any systemic diseases that delay wound healing.
- Deep sulcus
Show all 10Show fewer
- Thick gingival phenotype
- Pervious frenal procedures
- Pregnant or lactating females
- Pervious periodontal surgery within the last 6 months before the start of the trial
Trial locations and contacts
No sites are listed yet.
Manal Hosny, Professor contact
About this study
Official title: The Clinical Usage of a Free Gingival Graft Combined With Frenotomy in Patients With High Frenal Attachment: A Clinical Case Series
In patients with high frenal attachment will placement of free gingival graft combined with frenotomy result in gain of width of keratinized gingiva, decrease relapse, improve mucosal healing and have acceptable postoperative pain?
Read the detailed description
In patients with high frenal attachment will placement of free gingival graft combined with frenotomy result in gain of width of keratinized gingiva, decrease relapse, improve mucosal healing and have acceptable postoperative pain?
To the best of our knowledge there aren't any studies discussing the use of free gingival graft in combination with frenotomy procedure to decrease relapse \& morbidity of the condition; thus the objective of this case series study is to evaluate the effectiveness of using free gingival graft in combination with frenotomy procedure on increasing the width of keratinized tissue \& decreasing relapse, postoperative pain and scar formation.
Inclusion criteria:
Ages 18-40 years old Systemically healthy Gingival and plaque index <10 Good oral hygiene Highly attached mandibular labial frenum. Narrow sulcus depth Thin gingival phenotype
Exclusion criteria:
Smokers Poor oral hygiene Patient with a physical disability that hinders the upkeep of good oral hygiene measures.
Taking any medications that could affect healing Any systemic diseases that delay wound healing. Deep sulcus Thick gingival phenotype Pervious frenal procedures Pregnant or lactating females Pervious periodontal surgery within the last 6 months before the start of the trial
Interventions
Preoperative measures:
- All subjects will pass through phase I therapy (Supragingival scaling, subgingival debridement and oral hygiene instructions) before any surgical procedures.
- After 4 weeks, all subjects will be examined to determine patient compliance with oral hygiene procedures (tooth brushing twice daily and chlorhexidine HCL 1.25% mouthwash twice daily).
- Eligible \& complied patients will be enrolled in the study
Intervention - Surgical Phase (T0):
- The same operator (M S) will perform all procedures.
- After following complete aseptic precautions, surgical technique will be performed. Local infiltration will be done using local anaesthetic solution 4% articaine with 1/200 000 adrenaline solution.
- A horizontal incision will be placed at mucogingival junction using 15c blade with respect to teeth 42,41,31,32, which is then followed by supraperiosteal dissection or frenal relocation of the mandibular labial frenum up to the desired level using periosteal elevator.
- Undermining the edges of the frenum using periosteal elevator separating the epithelium from the underlining lip mucosa.
- The mucosa is sutured in the periosteum by using simple interrupted suture at the desired new level of the frenum.
- Gauze moistened with saline is to be placed over the recipient bed until graft placement.
- A free gingival autograft will be harvested from the palate using 15c blade and tissue forceps.
- Stabilization of the free gingival autograft in place using a 6-0 resorbable Vicryl suture using combination of interrupted and sling sutures.
Post-operative care:
- Patients abstained from tooth brushing for 2 days post-operatively.
- Using 0.2% cholohexidine mouthwash twice daily for 14 days to be started on the 2nd day of surgery.
- Ibuprofen 600 mg 1 tablet PRN.
- Patients will be instructed to:
- Follow the instructions completely.
- Keep up a strict follow-up schedule.
- Brush their teeth twice a day, with a soft brush, and avoid brushing the surgical area (to be started 2 days post-surgery).
- Not to touch the surgical area, with the tongue or fingers.
- Do not wear any kind of dental appliances, on or around the surgical site.
- Not to eat or bite on the anterior teeth during the healing period.
Follow-up (T1, T2,T3, T4):
T1 1. Patients recalled after 5 days for measurement of mucosal healing using IPR (Inflammatory, Proliferativ, \& Remodeling) Wound Healing Scale (Hamzani \& Chaushu, 2018).
T2
- Patients recalled after 14 days for suture removal.
- Measurement of pain score using Numerical Rating scale (NRS) measurement. (Williamson \& Hoggart, 2005).
- Measurement of mucosal healing using IPR (Inflammatory, Proliferativ, \& Remodeling) Wound Healing Scale (Hamzani \& Chaushu, 2018).
T3
- Patients recalled after 2 months.
- Measurement of mucosal healing using IPR (Inflammatory, Proliferativ, \& Remodeling) Wound Healing Scale (Hamzani \& Chaushu, 2018).
T4
- Patients recalled after 3 months for the evaluation of frenum relapse using periodontal probe (Sarmadi et al., 2021).
- Conditions
- High Frenum Attachment, Free Gingival Graft
- Being tested
- Combining free gingival graft with frenotomy procedure
- Keywords
- Frenotomy, Free gingival graft, High frenum attachment, Frenal relocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combining free gingival graft with frenotomy procedureBiological
The aim of the study is to evaluate the usage of free gingival graft combined with frenotomy in order to measure the gain in the width of keratinized gingiva, relapse, mucosal healing and postoperative pain.
| Study group | Role | What they receive |
|---|---|---|
| Combining Free Gingival Graft with frenotomy procedure | Experimental | evaluate the usage of free gingival graft combined with frenotomy in order to measure the gain in the width of keratinized gingiva, relapse, mucosal healing and postoperative pain. Receives: Biological: Combining free gingival graft with frenotomy procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Width of keratinized tissue
It will be measured using periodontal probe at T1, T2, T3 and T4
Measured: T1: 5days post-surgery, T2:14 days post-surgery, T3: 2months post-surgery & T4: 3months post-surgery.
Secondary outcomes (3)
Mucosal healing
it will be measured using IPR (Inflammatory Proliferative Remodeling) Wound Healing Scale at T1, T2 and T3.
Measured: T1: 5days post-surgery, T2:14 days post-surgery, T3: 2months post-surgery
Post-operative pain
it will be measured using Numerical Rating scale (NRS) at T2
Measured: T2:14 days post-surgery.
Relapse
it will be measured using periodontal probe at T4
Measured: T4: 3months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Frenum AttachmentStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case Series
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Saleh Saleh Saleh, Cairo University
- Investigators
- Manal Hosny, Professor, Study director, Cairo UniversityNada Zazou, Ass Lecturer, Study chair, MSA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102642
- Sponsor's protocol ID
- MohSaleh123
- Status last verified
- Oct 2023
- First submitted
- 21 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Usage of a Free Gingival Graft Combined With Frenotomy in Patients With High Frenal Attachment: A Clinical Case Series
- ClinicalTrials.gov ID
- NCT06102642
- Acronym / sponsor ID
- MohSaleh123
- Conditions
- High Frenum Attachment, Free Gingival Graft
- Keywords
- Frenotomy, Free gingival graft, High frenum attachment, Frenal relocation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 26 Oct 2023 (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.
In patients with high frenal attachment will placement of free gingival graft combined with frenotomy result in gain of width of keratinized gingiva, decrease relapse, improve mucosal healing and have acceptable postoperative pain?
Detailed description
In patients with high frenal attachment will placement of free gingival graft combined with frenotomy result in gain of width of keratinized gingiva, decrease relapse, improve mucosal healing and have acceptable postoperative pain?
To the best of our knowledge there aren't any studies discussing the use of free gingival graft in combination with frenotomy procedure to decrease relapse \& morbidity of the condition; thus the objective of this case series study is to evaluate the effectiveness of using free gingival graft in combination with frenotomy procedure on increasing the width of keratinized tissue \& decreasing relapse, postoperative pain and scar formation.
Inclusion criteria:
Ages 18-40 years old Systemically healthy Gingival and plaque index <10 Good oral hygiene Highly attached mandibular labial frenum. Narrow sulcus depth Thin gingival phenotype
Exclusion criteria:
Smokers Poor oral hygiene Patient with a physical disability that hinders the upkeep of good oral hygiene measures.
Taking any medications that could affect healing Any systemic diseases that delay wound healing. Deep sulcus Thick gingival phenotype Pervious frenal procedures Pregnant or lactating females Pervious periodontal surgery within the last 6 months before the start of the trial
Interventions
Preoperative measures:
- All subjects will pass through phase I therapy (Supragingival scaling, subgingival debridement and oral hygiene instructions) before any surgical procedures.
- After 4 weeks, all subjects will be examined to determine patient compliance with oral hygiene procedures (tooth brushing twice daily and chlorhexidine HCL 1.25% mouthwash twice daily).
- Eligible \& complied patients will be enrolled in the study
Intervention - Surgical Phase (T0):
- The same operator (M S) will perform all procedures.
- After following complete aseptic precautions, surgical technique will be performed. Local infiltration will be done using local anaesthetic solution 4% articaine with 1/200 000 adrenaline solution.
- A horizontal incision will be placed at mucogingival junction using 15c blade with respect to teeth 42,41,31,32, which is then followed by supraperiosteal dissection or frenal relocation of the mandibular labial frenum up to the desired level using periosteal elevator.
- Undermining the edges of the frenum using periosteal elevator separating the epithelium from the underlining lip mucosa.
- The mucosa is sutured in the periosteum by using simple interrupted suture at the desired new level of the frenum.
- Gauze moistened with saline is to be placed over the recipient bed until graft placement.
- A free gingival autograft will be harvested from the palate using 15c blade and tissue forceps.
- Stabilization of the free gingival autograft in place using a 6-0 resorbable Vicryl suture using combination of interrupted and sling sutures.
Post-operative care:
- Patients abstained from tooth brushing for 2 days post-operatively.
- Using 0.2% cholohexidine mouthwash twice daily for 14 days to be started on the 2nd day of surgery.
- Ibuprofen 600 mg 1 tablet PRN.
- Patients will be instructed to:
- Follow the instructions completely.
- Keep up a strict follow-up schedule.
- Brush their teeth twice a day, with a soft brush, and avoid brushing the surgical area (to be started 2 days post-surgery).
- Not to touch the surgical area, with the tongue or fingers.
- Do not wear any kind of dental appliances, on or around the surgical site.
- Not to eat or bite on the anterior teeth during the healing period.
Follow-up (T1, T2,T3, T4):
T1 1. Patients recalled after 5 days for measurement of mucosal healing using IPR (Inflammatory, Proliferativ, \& Remodeling) Wound Healing Scale (Hamzani \& Chaushu, 2018).
T2
- Patients recalled after 14 days for suture removal.
- Measurement of pain score using Numerical Rating scale (NRS) measurement. (Williamson \& Hoggart, 2005).
- Measurement of mucosal healing using IPR (Inflammatory, Proliferativ, \& Remodeling) Wound Healing Scale (Hamzani \& Chaushu, 2018).
T3
- Patients recalled after 2 months.
- Measurement of mucosal healing using IPR (Inflammatory, Proliferativ, \& Remodeling) Wound Healing Scale (Hamzani \& Chaushu, 2018).
T4
- Patients recalled after 3 months for the evaluation of frenum relapse using periodontal probe (Sarmadi et al., 2021).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case Series
| Arm | Type | Receives |
|---|---|---|
| Combining Free Gingival Graft with frenotomy procedure | Experimental | Biological: Combining free gingival graft with frenotomy procedureevaluate the usage of free gingival graft combined with frenotomy in order to measure the gain in the width of keratinized gingiva, relapse, mucosal healing and postoperative pain. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Ages 18-40 years old
- Systemically healthy
- Gingival and plaque index <10
- Good oral hygiene
- Highly attached mandibular labial frenum.
Key exclusion criteria (10 listed)
- Smokers
- Poor oral hygiene
- Patient with a physical disability that hinders the upkeep of good oral hygiene measures.
- Taking any medications that could affect healing
- Any systemic diseases that delay wound healing.
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 |
|---|---|---|
| Combining free gingival graft with frenotomy procedureThe aim of the study is to evaluate the usage of free gingival graft combined with frenotomy in order to measure the gain in the width of keratinized gingiva, relapse, mucosal healing and postoperative pain. | Biological | Combining Free Gingival Graft with frenotomy procedure |
Primary outcome
Width of keratinized tissue
Time frame: T1: 5days post-surgery, T2:14 days post-surgery, T3: 2months post-surgery & T4: 3months post-surgery.
It will be measured using periodontal probe at T1, T2, T3 and T4
3 secondary outcomes
Mucosal healing
Time frame: T1: 5days post-surgery, T2:14 days post-surgery, T3: 2months post-surgery
Post-operative pain
Time frame: T2:14 days post-surgery.
Relapse
Time frame: T4: 3months post-surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
Related trials for High Frenum Attachment
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.
Manal Hosny, Professor contact
Manal Hosny, Professor study director
Cairo University
Nada Zazou, Ass Lecturer study chair
MSA University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combining free gingival graft with frenotomy procedure in people with High Frenum Attachment and Free Gingival Graft, run by Cairo University.
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 10 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: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed S. Saleh, Bachelor (01008882296 ext. +02, mohammed-saleh@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Width of keratinized tissue (time frame: T1: 5days post-surgery, T2:14 days post-surgery, T3: 2months post-surgery & T4: 3months post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2023.