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Not yet recruitingNCT06102642Updated Oct 26, 2023

The Clinical Usage of a Free Gingival Graft Combined With Frenotomy in Patients With High Frenal Attachment

A Phase 4 interventional study of Combining free gingival graft with frenotomy procedure in High Frenum Attachment and Free Gingival Graft, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-26.

Sponsored by Cairo University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study 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 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:

    1. Follow the instructions completely.
    2. Keep up a strict follow-up schedule.
    3. Brush their teeth twice a day, with a soft brush, and avoid brushing the surgical area (to be started 2 days post-surgery).
    4. Not to touch the surgical area, with the tongue or fingers.
    5. Do not wear any kind of dental appliances, on or around the surgical site.
    6. 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).
02

Conditions studied

  • High Frenum Attachment
  • Free Gingival Graft

Keywords

  • Frenotomy
  • Free gingival graft
  • High frenum attachment
  • Frenal relocation
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Combining Free Gingival Graft with frenotomy procedure

    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

Interventions

  • BiologicalCombining free gingival graft with frenotomy procedure

    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.

06

What researchers measure

Primary outcomes

  1. Width of keratinized tissue

    It will be measured using periodontal probe at T1, T2, T3 and T4

    Time frame: T1: 5days post-surgery, T2:14 days post-surgery, T3: 2months post-surgery & T4: 3months post-surgery.

Secondary outcomes

  1. Mucosal healing

    it will be measured using IPR (Inflammatory Proliferative Remodeling) Wound Healing Scale at T1, T2 and T3.

    Time frame: 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

    Time frame: T2:14 days post-surgery.

  3. Relapse

    it will be measured using periodontal probe at T4

    Time frame: T4: 3months post-surgery.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06102642
Lead sponsor
Cairo University
Responsible party
Mohammed Saleh Saleh Saleh (Master degree student, periodontology department, faculty of dentistry, Cairo University., Cairo University) — Principal investigator
First posted
Oct 26, 2023
Start date
Oct 2023 (estimated)
Primary completion
Mar 2024 (estimated)
Completion
Aug 2024 (estimated)
Last update
Oct 26, 2023

Study contacts

Mohammed S. Saleh, Bachelor
Contact
mohammed-saleh@dentistry.cu.edu.eg
01008882296 ext. +02
Manal Hosny, Professor
Contact
manal.hosny@dentistry.cu.edu.eg
Manal Hosny, Professor
study director · Cairo University
Nada Zazou, Ass Lecturer
study chair · MSA University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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