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NCT Number: NCT05688293

Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries

Thin gingival phenotype is one of the major causative factors of gingival recession type 1 which can result in hypersensitivity, discomfort, and compromised esthetics. This study assess the efficacy of increasing the gingival thickness from thin gingival phenotype to thick gingival phenotype in the treatment of patients suffering from gingival recession (RT1) and maintenance of results using either connective tissue graft or de-epithelized free gingival graft after non-surgical periodontal debridement compared to non-surgical periodontal debridement alone.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of oral and dental medicine, Misr international university

Cairo, 12345, Egypt

Location status: Recruiting

Location contact

Yahia amer, Lecturer

CONTACT

[email protected]

Zainab Hafez, Lecturer

CONTACT

[email protected]

About this study

This parallel arm randomized controlled clinical trial study will include systematically free patients with thin gingival phenotype. They will be randomly allocated to three equal groups. Group A (test group, n=10) will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique, Group B (test group, n=10) will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft, while group C (control group, n=10) will receive non-surgical periodontal treatment only. After 3, 6 and 12 months gingival biotype will be clinically assessed (1ry outcome). This parameter will be recorded at baseline, 3, 6 and 12 months. The 2ry outcomes will include recording of recession depth, plaque index, bleeding on probing, keratinized tissue width . Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be masked. Follow-up will be performed to assess the outcomes and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medically free patients (American Society of Anesthesiologists I; ASA I)
  • Patients diagnosed with recession (RT1)
  • Fair oral hygiene
  • Patient accepting to provides an informed consent and the follow-up

Exclusion criteria

  • Carious teeth and teeth with periapical infection.
  • Patients diagnosed with periodontitis
  • Smokers
  • Pregnant and lactating females

Treatment and study plan

connective tissue graft

Procedure

non-surgical periodontal treatment and connective tissue graft

Free gingival graft

Procedure

will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft

Non surgical

Procedure

non-surgical periodontal treatment only

Primary outcomes

  1. Gingival phenotype change

    Time frame: at baseline 3,6 and 12 months

    determination of the change in gingival thickness in mm using periodontal probe

Secondary outcomes

  1. Keratinized tissue width

    Time frame: at baseline 3,6 and 12 months

    determination of Keratinized tissue width in mm using periodontal probe

  2. Root coverage esthetic score (RES)

    Time frame: at baseline 3,6 and 12 months

    It is a scoring system to assess the level of gingival margin (GM),marginal tissue contour (MTC),Soft tissue texture, Mucogingival alignment (MGJ),Gingival color The score is 0,1 and 3 where 0 is the minimum and 3 is the maximum

Study contacts

Contact information is provided by the study sponsor or research team.

Shahinaz Al ashiry, Asso. Prof

CONTACT

[email protected]

Zainab Hafez, Lecturer

CONTACT

[email protected]

+01221334637

Sponsors and collaborators

Lead sponsor

Misr International University

Other

Registry information

Official study title

Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries Compared With Untreated Contralateral Sites: A Randomized Controlled Clinical Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 18, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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