Management of Miller Class I & II Gingival Recession

Management of Miller Class I & II Gingival Recession Using Conventional Versus Abrasive De-epithelization of Palatal Graft

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.

Study Overview

• Status: Unknown
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: coronally advanced flap with abrasive de-epithelized graft.; Procedure: coronally advanced flap with de-epithelized graft.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; SCTG will be harvested from the palate in the intervention group (coronally advanced flap and abrasively de-epithelialized free gingival graft)	Procedure: coronally advanced flap with abrasive de-epithelized graft.; SCTG will be harvested from the palate by abrasive de-epithelialization of palatal graft involves removing the epithelium of the selected area with a high-speed hand piece and diamond bur
Active Comparator: Control group; 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)	Procedure: coronally advanced flap with de-epithelized graft.; SCTG will be harvested from the palate by abrasive de-epithelialization of palatal graft involves removing the epithelium of the selected area with a blade

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Direct Post-operative pain	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.	7 days
Indirect Post-operative pain	Indirectly will be evaluated on the basis of the mean consumption of analgesics	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Root Coverage	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	6 months
Recession depth.	Measured from the CEJ to the most apical extension of the gingival margin	6 months
Gingival Recession Width	measured at the level of the CEJ.	6 months
Width Of Keratinized Gingiva	Measured from the gingival margin to the mucogingival line	6 months
Root Coverage Esthetic Score	The RES system evaluates five variables 6 months following surgery	6 months
Gingival thickness	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.	6 months
Surgical chair time	measured by Stop watch	at the time of surgery

Collaborators and Investigators

• Sponsor: Halla Gamal Mohammed Esmail

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 1788

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No