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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

manal.hosny@dentistry.cu.edu.eg

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:

  1. All subjects will pass through phase I therapy (Supragingival scaling, subgingival debridement and oral hygiene instructions) before any surgical procedures.
  2. 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).
  3. Eligible \& complied patients will be enrolled in the study

Intervention - Surgical Phase (T0):

  1. The same operator (M S) will perform all procedures.
  2. 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.
  3. 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.
  4. Undermining the edges of the frenum using periosteal elevator separating the epithelium from the underlining lip mucosa.
  5. The mucosa is sutured in the periosteum by using simple interrupted suture at the desired new level of the frenum.
  6. Gauze moistened with saline is to be placed over the recipient bed until graft placement.
  7. A free gingival autograft will be harvested from the palate using 15c blade and tissue forceps.
  8. 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:

  1. Patients abstained from tooth brushing for 2 days post-operatively.
  2. Using 0.2% cholohexidine mouthwash twice daily for 14 days to be started on the 2nd day of surgery.
  3. Ibuprofen 600 mg 1 tablet PRN.
  4. Patients will be instructed to:
  5. Follow the instructions completely.
  6. Keep up a strict follow-up schedule.
  7. Brush their teeth twice a day, with a soft brush, and avoid brushing the surgical area (to be started 2 days post-surgery).
  8. Not to touch the surgical area, with the tongue or fingers.
  9. Do not wear any kind of dental appliances, on or around the surgical site.
  10. 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

  1. Patients recalled after 14 days for suture removal.
  2. Measurement of pain score using Numerical Rating scale (NRS) measurement. (Williamson \& Hoggart, 2005).
  3. Measurement of mucosal healing using IPR (Inflammatory, Proliferativ, \& Remodeling) Wound Healing Scale (Hamzani \& Chaushu, 2018).

T3

  1. Patients recalled after 2 months.
  2. Measurement of mucosal healing using IPR (Inflammatory, Proliferativ, \& Remodeling) Wound Healing Scale (Hamzani \& Chaushu, 2018).

T4

  1. Patients recalled after 3 months for the evaluation of frenum relapse using periodontal probe (Sarmadi et al., 2021).
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 groups in NCT06102642
Study groupRoleWhat they receive
Combining Free Gingival Graft with frenotomy procedureExperimentalevaluate 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.

  1. 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)
  1. 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

  2. Post-operative pain

    it will be measured using Numerical Rating scale (NRS) at T2

    Measured: T2:14 days post-surgery.

  3. 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.

  1. First posted26 Oct 2023
  2. Study startOct 2023 (estimated)
  3. Primary completionMar 2024 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

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)
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

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.

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