Management of Miller Class I & II Gingival Recession

Not Applicable

• Conditions: Gingival Recession
• Interventions: Procedure: coronally advanced flap with abrasive de-epithelized graft.; Procedure: coronally advanced flap with de-epithelized graft.

• Registration Number: NCT03767309
• Lead Sponsor: Halla Gamal Mohammed Esmail

Brief Summary

Management of Miller class I \& II gingival recession using coronally advanced flap combined with conventional de-epithelialized free gingival graft versus coronally advanced flap combined with abrasive de-epithelized connective tissue graft Null hypothesis: In patients with Miller class I and II gingival recession, there is no difference between coronally advanced flap with conventional de-epithelialized free gingival graft and coronally advanced flap with abrasive de-epithelized connective tissue graft in recession depth reduction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-29
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-06
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-17
• Study Start: 2019-02-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age ≥ 18 years.
• Systemically healthy patients.
• Miller's Class I and II recession defects with recession depth ≥ 2mm.
• Presence of identifiable cemento-enamel junction (CEJ).
• Clinical indication and/or patient request for recession coverage.
• Smoking ≤ 10 cigarettes/day.
• Cooperative patients able and accept to come for follow up appointments.

Exclusion Criteria

• Pregnant females.
• Smoking ˃ 10 cigarettes/day.
• Contraindication for periodontal surgery.
• Patients with poor oral hygiene.
• Recession defects associated with caries or restoration as well as
• Teeth with evidence of a pulpal pathology
• Molar teeth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	coronally advanced flap with abrasive de-epithelized graft.	SCTG will be harvested from the palate in the intervention group (coronally advanced flap and abrasively de-epithelialized free gingival graft)
Control group	coronally advanced flap with de-epithelized graft.	SCTG will be harvested from the palate using Zucchilli's technique (zucchelli, 2010) in the control group (coronally advanced flap and conventionally de-epithelialized free gingival graft)

Primary Outcome Measures

Name	Time	Method
Direct Post-operative pain	7 days	Directly will be evaluated post-surgically with Visual Analogue Scale with numbers from 0 to 10 that given to the patients at 7 days follow-up visits.
Indirect Post-operative pain	7 days	Indirectly will be evaluated on the basis of the mean consumption of analgesics

Secondary Outcome Measures

Name	Time	Method
Root Coverage Esthetic Score	6 months	The RES system evaluates five variables 6 months following surgery
Surgical chair time	at the time of surgery	measured by Stop watch
Complete Root Coverage	6 months	CRC evaluated in patients by single operator clinically using a periodontal probe. Root coverage was deemed complete when the gingival margin is at or above the level of CEJ
Recession depth.	6 months	Measured from the CEJ to the most apical extension of the gingival margin
Gingival Recession Width	6 months	measured at the level of the CEJ.
Width Of Keratinized Gingiva	6 months	Measured from the gingival margin to the mucogingival line
Gingival thickness	6 months	It will be measured by penetrating the gingiva mid-buccally in the attached gingiva, half way between mucogingival junction and free gingival groove with the periodontal probe after giving local anesthesia to measure the thickness of gingival tissues.