Management of Miller Class I & II Gingival Recession

NCT03767309 | Unknown DMC

• 1 other identifier: 1788
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Complete Root Coverage

  6 months

• Recession depth.

  6 months

• Gingival Recession Width

  6 months

• Width Of Keratinized Gingiva

  6 months

• Root Coverage Esthetic Score

  6 months

Study Arms (2)

Test group

EXPERIMENTAL

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.

Control group

ACTIVE COMPARATOR

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.

Interventions

coronally advanced flap with abrasive de-epithelized graft. PROCEDURE

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

Test group

coronally advanced flap with de-epithelized graft. PROCEDURE

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Halla Gamal Mohammed Esmail: lead

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 6, 2018
• Study Start: February 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 17, 2019

Record last verified: 2018-12