Skip to main content
OpenTrials
Completed

NCT Number: NCT03213483

Soft Tissue Augmentation Using Deepithelialized Free Gingival Graft Compared to Connective Tissue Graft in Management of Miller Class I and II Gingival Recession.

The aim of this study will be to clinically assess the soft tissue augmentation achieved by the de-epithelialized free gingival graft with coronally advanced flap versus the subepithelial connective tissue graft with coronally advanced flap as root coverage procedures for management of patients with Miller class I and II gingival recession.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine

Cairo, 12114, Egypt

About this study

Evidence from the literature showed that coronally advanced flap was a predictable method for root coverage. The addition of a connective tissue graft was also found to improve the outcome of obtaining complete root coverage in Miller class I and II gingival recession. Many different connective tissue graft-harvesting techniques have been utilized. These techniques aimed at reducing patient morbidity by primary closure of the palatal flap to achieve primary intention wound healing. However, they had the limitation of requiring an adequate thickness of the palatal fibromucosa in order to prevent desquamation of the undermined flap and compromised vasculature.

On the other hand, the free gingival graft surgical technique was also unaccepted esthetically due to the white scar and irregularities produced at the monolingual junction.

Moreover, despite the fact that the free gingival graft had its limitation of being associated with greater post-operative pain, discomfort and bleeding due to healing by secondary intention in 2-4 weeks, nevertheless, this technique was much easier to perform and could be used even in cases of thin palatal fibromucosa.

The evidence in literature comparing patient morbidity and root coverage outcomes between these two techniques is minimal. Studies by Griffin et al. (2006) and Wessel and Tatakis (2008) reported increased incidence of post-operative pain with free gingival grafts. However, a recently study by Zucchelli et al. (2010) compared post-operative morbidity and root coverage outcomes in patients treated with trap-door connective tissue graft and de-epithelialized free gingival graft found no statistically significant differences in pain killer consumption, post-operative discomfort and bleeding between the two groups.

Still very few studies measured the effect of different connective tissue graft harvesting techniques on gingival thickness. And even in the study by Zucchelli et al. (2010), only speculative explanation was given regarding the increase of gingival thickness in case of a de-epithelialized free gingival graft than subepithelial connective tissue graft.

Gingival thickness was proved to be an important factor for the etiology of gingival recession as thick gingival tissues are able to confine the inflammation within the region of the gingival sulcus and prevent its extension to destroy the outer gingival tissue leading to gingival recession.

Therefore, this study will monitor the effect of different connective tissue harvesting techniques (De-epithelialized free gingival graft versus subepithelial connective tissue graft) on gingival thickness enhancement. It will also evaluate the de-epithelialized free gingival graft as a harvesting mechanism for connective tissue graft in terms of patient morbidity and root coverage outcomes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients 18 years or older.
  • Periodontally and systemically healthy.
  • Buccal recession defects classified as either Miller class I or II.
  • Presence of identifiable Cementoenamel juction (Zucchelli et al., 2010).
  • Clinical indication and/or patient request for recession coverage.
  • O'Leary index less than 20% (O'Leary et al., 1972).

Exclusion criteria

  • Miller class III or IV recession defects.
  • Pregnant females.
  • Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
  • Handicapped and mentally retarded patients.
  • Patients undergoing radiotherapy.
  • Teeth with cervical restorations, abrasion.
  • Presence of systemic disease that would affect wound healing.

Treatment and study plan

Coronally advanced flap and subepithelial connective tissue graft

Procedure

The connective tissue graft is obtained by a single line incision from the palate.

Coronally advanced flap and deepithelialized free gingival graft

Procedure

The connective tissue graft is obtained by deepithelialization of a free gingival graft.

Primary outcomes

  1. Gingival Thickness

    Time frame: 6 months

    Thickness of the gingival tissues 2 mm from the free gingival margin

Secondary outcomes

  1. Percentage of root coverage

    Time frame: 6 months

    (Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.

  2. Root coverage esthetic score

    Time frame: 6 months

    A system proposed for evaluating esthetic outcomes of root coverage procedures.

  3. Post-Operative Pain

    Time frame: Two weeks

    Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 weeks postoperatively

  4. Post-operative stress

    Time frame: Two weeks

    level of stress experienced by the patients of jeopardizing the palatal wound during the time of healing

  5. Post-operative bleeding

    Time frame: Two weeks

    prolonged hemorrhaging during the post-surgical week reported by the patients measured by a questionnaire as a categorical yes or no question.

  6. Post-operative inability to chew

    Time frame: Two weeks

    Will be described as the level of variation of the patient's eating habits due to the presence of the palatal wound.

  7. Post-Surgical Patient Satisfaction

    Time frame: 6 months

    A 3-item questionnaire is asked and the patients shall use a 7-point answer scale.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Soft Tissue Augmentation Using Deepithelialized Free Gingival Graft Compared to Connective Tissue Graft in Management of Miller Class I and II Gingival Recession. A Randomized Controlled Clinical Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2017
Registry last updated
Aug 13, 2019

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.

Published trials that share one or more normalized conditions with this study.