NCT06044870

Brief Summary

Regression analysis in a recent systematic review showed significantly greater mRC and CRC values when modifications are done to the TUN procedure to achieve more coronal advancement of the flap, coronal advancement also helps in covering the underlying graft for better recession coverage outcomes (Tavelli et al., 2018), limited data is present on the possible influence of a covered or partially uncovered graft. However, it has been suggested that minimal exposure of the CTG may aid not only in achieving CRC but also a harmonious gingival margin (John et al., 2015; Rasperini et al., 2011).

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

October 2, 2025

Status Verified

October 1, 2025

Enrollment Period

2.1 years

First QC Date

September 12, 2023

Last Update Submit

October 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recession depth reduction.

    Measured as the difference between the recession gingival depth at different follow up intervals and the baseline.

    1 year

Secondary Outcomes (7)

  • Mean root coverage

    1 year

  • Recession depth

    1 year

  • Recession width

    1 year

  • Soft tissue thickness

    1 year

  • Keratinized tissue width

    1 year

  • +2 more secondary outcomes

Study Arms (2)

Modified laterally stretched technique with a connective tissue graft.

EXPERIMENTAL

After the administration of local anesthesia, root planing of the exposed root surfaces will be performed by means of hand instruments. A partial thickness envelope is performed with tunneling instruments involving one or two teeth adjacent to the tooth, in case of a very thin biotype a complete thickness envelope could be done. Two horizontal incisions are done at the base of the papillae of the deepest recession site, allowing to place the graft in a more coronal position and improving access and visibility.

Procedure: Modified laterally stretched technique with a connective tissue graft.

Tunneling technique with connective tissue graft.

ACTIVE COMPARATOR

Immediately before surgery, contact point composite stops were placed to prevent the collapse of the suspended sutures in the inter-proximal spaces.• The entire gingival papillary complex will be moved coronally using a suspended suture anchored in the lingual gingiva (Aroca et al., 2010, 2013; Azzi et al, 2002, zuhr et al.,2009).

Procedure: Modified laterally stretched technique with a connective tissue graft.

Interventions

Modified laterally stretched technique with a connective tissue graft.

Modified laterally stretched technique with a connective tissue graft.Tunneling technique with connective tissue graft.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Pregnant or lactating females.
  • deep recession sites more than 5 mm
  • Tobacco smoking.
  • Uncontrolled medical conditions.
  • Uncooperative patients or unable to complete the study.
  • Patients treated with any medication known to cause gingival hyperplasia.
  • No occlusal interferences.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

September 12, 2023

First Posted

September 21, 2023

Study Start

September 1, 2023

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

October 2, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations