Management of Miller Class I & II Gingival Recession

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03767309
• Other study ID #: 1788
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Halla Gamal Mohammed Esmail

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Indirect Post-operative pain	Indirectly will be evaluated on the basis of the mean consumption of analgesics	7 days
Secondary	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
Secondary	Recession depth.	Measured from the CEJ to the most apical extension of the gingival margin	6 months
Secondary	Gingival Recession Width	measured at the level of the CEJ.	6 months
Secondary	Width Of Keratinized Gingiva	Measured from the gingival margin to the mucogingival line	6 months
Secondary	Root Coverage Esthetic Score	The RES system evaluates five variables 6 months following surgery	6 months
Secondary	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
Secondary	Surgical chair time	measured by Stop watch	at the time of surgery