NCT06529640

Brief Summary

Gingival recession is defined as the apical shift of the marginal gingiva from its normal position on the crown of the tooth to levels on the root surface beyond the cemento-enamel junction (CEJ).Various surgical procedures including repositioned flaps as well as autogenous and other type grafts have been used in the treatment of gingival recession.The present gold standard technique is the bilaminar technique using the subepithelial connective tissue graft (SCTG) which provides for long-term stability but also increases tissue morbidity.Hence, a suitable alternative technique - the periosteal pedicle flap (PPF) - has been practiced, which is less invasive, does not require a second surgical site, and provides a graft of adequate dimensions.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

July 26, 2024

Last Update Submit

July 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • the percentage of root coverage (%RC)

    to measure the coverage percentage of root recession by UNC periodontal probe Preoperative recession depth - Postoperative recession depth /Preoperative recession depth x 100

    at base line, 1 month and 3 months after treatment

Secondary Outcomes (4)

  • recession depth

    at base line, 1 month and 3 months after treatment

  • recession width

    at base line, 1 month and 3 months after treatment

  • clinical attachment gain

    at base line, 1 month and 3 months after treatment

  • keratinized tissue gain

    at base line, 1 month and 3 months after treatment

Study Arms (2)

Subepothelial connective tissue graft (SCTG) group

ACTIVE COMPARATOR

Subepithelial connective tissue graft from palate then coronally positioning flap to cover root recession

Procedure: SCTG followed by coronally postionting flap

Periosteal pedicle flap (PPF) group

ACTIVE COMPARATOR

periosteal flap elevation and repositioning to the root then coronally positioning flap to cover root recession

Procedure: periosteal flap followed by coronally postionting flap

Interventions

The SCTG will be harvested from the palate followed by coronally postionting flap

Subepothelial connective tissue graft (SCTG) group

he periosteal pedicle graft obtained is then turned over the exposed root surface then followed by coronally postionting flap

Periosteal pedicle flap (PPF) group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with one or more Miller's Class 1 and Class II buccal recessions demonstrating ≤20% of plaque and bleeding scores, respectively, after Phase I therapy.
  • age from 18 th 60 years.

You may not qualify if:

  • Smokers
  • patients with malposed or crowded teeth
  • pregnant and lactating women
  • patients using medications that could affect the periodontal status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Oral medicine, Periodontology and Oral diagnosis, Faculty of dentistry

Study Record Dates

First Submitted

July 26, 2024

First Posted

July 31, 2024

Study Start

August 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07