Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06102642 |
| Other study ID # |
MohSaleh123 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
October 2023 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Cairo University |
| Contact |
Mohammed S. Saleh, Bachelor |
| Phone |
01008882296 |
| Email |
mohammed-saleh[@]dentistry.cu.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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?
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).
