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
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?
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:
Intervention - Surgical Phase (T0):
Post-operative care:
Patients will be instructed to:
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
T3
T4
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.
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Exclusion Criteria:
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.
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.
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
Post-operative pain
it will be measured using Numerical Rating scale (NRS) at T2
Time frame: T2:14 days post-surgery.
Relapse
it will be measured using periodontal probe at T4
Time frame: T4: 3months post-surgery.
No study locations are listed for this record.
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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Cairo University