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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06102642
Collaborator
(none)
12
1
10

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Biological: Combining free gingival graft with frenotomy procedure
Phase 4

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Case SeriesCase Series
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Clinical Usage of a Free Gingival Graft Combined With Frenotomy in Patients With High Frenal Attachment: A Clinical Case Series
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. Width of keratinized tissue [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

Secondary Outcome Measures

  1. Mucosal healing [T1: 5days post-surgery, T2:14 days post-surgery, T3: 2months post-surgery]

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

  2. Post-operative pain [T2:14 days post-surgery.]

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

  3. Relapse [T4: 3months post-surgery.]

    it will be measured using periodontal probe at T4

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

  • Study Director: Manal Hosny, Professor, Cairo University
  • Study Chair: Nada Zazou, Ass Lecturer, MSA University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohammed Saleh Saleh Saleh, Master degree student, periodontology department, faculty of dentistry, Cairo University., Cairo University
ClinicalTrials.gov Identifier:
NCT06102642
Other Study ID Numbers:
  • MohSaleh123
First Posted:
Oct 26, 2023
Last Update Posted:
Oct 26, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohammed Saleh Saleh Saleh, Master degree student, periodontology department, faculty of dentistry, Cairo University., Cairo University

Study Results

No Results Posted as of Oct 26, 2023