Clinical trial NCT06102642: The Clinical Usage of a Free Gingival Graft Combined With Frenotomy in Patients With High Frenal Attachment
Official title: The Clinical Usage of a Free Gingival Graft Combined With Frenotomy in Patients With High Frenal Attachment: A Clinical Case Series
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: High Frenum Attachment
Free Gingival Graft
Keywords: Frenotomy
Free gingival graft
High frenum attachment
Frenal relocation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case Series
Primary purpose: TREATMENT

Brief 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?

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).

Eligibility criteria: 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

Primary outcomes:
measure: Width of keratinized tissue
timeFrame: T1: 5days post-surgery, T2:14 days post-surgery, T3: 2months post-surgery & T4: 3months post-surgery.
Secondary outcomes:
measure: Mucosal healing
timeFrame: T1: 5days post-surgery, T2:14 days post-surgery, T3: 2months post-surgery
measure: Post-operative pain
timeFrame: T2:14 days post-surgery.
measure: Relapse
timeFrame: T4: 3months post-surgery.
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Manal Hosny, Professor
role: STUDY_DIRECTOR
affiliation: MSA University
name: Nada Zazou, Ass Lecturer
role: STUDY_CHAIR
References: