Connective Tissue Graft Wall Technique in Management of Cairo's RT2 and RT3 With Intra-bony Defects

August 29, 2022 updated by: Mariam Galal Bendary, Cairo University

Evaluation of a De-epithelialized Free Gingival Connective Tissue Graft Wall Technique in Management of Cairo's RT2 and RT3 With Intra-bony Defects: A Case Series

Recession presents a day to day challenge due to the high esthetic demand of the patients. The prevalence, extent, and severity of recession associated with intra-bony defects due to periodontitis increases with age rendering the success of the root coverage procedures questionable due to loss of interdental papillary support. .

Therefore, connective tissue graft wall technique in cases of Cairo's RT2 and RT3 gingival recession associated with intra bony defects seems promising with regard to recession depth reduction and radiographic bone fill.

Study Overview

Status

Completed

Conditions

Detailed Description

Recession is usually treated by an array of mucogingival surgical techniques. The choice of the procedure depends on the morphology of the recession defect. Full root coverage in RT2 and RT3 gingival recession defects cannot always be predictably achieved due to the presence of bone loss. Improvement is further complicated when these recessions are associated with intra-bony defects as mucogingival surgical techniques are not designed to treat intra-bony defects. The preferred surgical modality for treatment of intrabony defects is guided tissue regeneration. However when considering recession defects, the amount of root coverage achieved by GTR may be limited with less results achieved.

Most of the root coverage procedures have proven to be successful, however, when recession is associated with intrabony defect especially in cases of low height and thickness of keratinized tissue and GTR is performed, the treatment results were unpredictable and it was found that the recession might increase post-surgically, so the procedure might offer a limited benefit.

Therefore, the technique introduced by Zucchelli et al. in 2014 in cases of RT2 and RT3 gingival recession associated with intra bony defects seems promising with regard to recession depth reduction and radiographic bone fill. A simplified papilla preservation technique was performed on the defect site, a de-epithelialized free gingival graft was used to treat the gingival recession present and intrabony defects because it acted as a membrane, creating a buccal wall to the intra-bony defect from one side and on the palatal aspect since no flap elevation was done. The palatal connective tissue acted as a palatal wall preventing gingival epithelium and connective tissue from contacting the space created allowing both improved root coverage and bone fill. He reported interproximal probing depth reduction, clinical attachment gain, improvement in the papilla covering the intrabony defect regarding the gingival thickness and root coverage and complete bone fill was shown radiographically in 1 year.

This technique needs more investigations, but it seems encouraging to improve regenerative and esthetic parameters in the treatment of deep infrabony defects, in one surgical session.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt, 11552
        • Faculty of dentistry cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Teeth with buccal RT2 and RT3 recession associated with an intra-bony defect on single rooted teeth.
  • Single and multiple recessions.
  • Full mouth plaque score (FMPS )<20% at baseline.
  • Full mouth bleeding score (FMBS )<10% at baseline.
  • Systemically healthy.
  • Cooperative patients.

Exclusion Criteria:

  • Smokers.
  • Pregnancy and lactation.
  • Stage 4 Grade C periodontitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: De-epithelialized connective tissue graft wall

Simplified papilla preservation flap will be applied in the narrow interproximal spaces (≤2 mm), where an oblique incision starting from the gingival margin at the buccal-line angle of the involved tooth reaching the mid-interproximal portion of the papilla under the contact point of the adjacent tooth will be performed using a 15c blade.

A free gingival graft will be obtained from the hard palate and de-epithelized extra-orally.

A Coronally advanced flap will be performed. The de-epithelialized FGG will be sutured coronally using a 6-0 vicryl suture to the anatomical papillae of the two teeth adjacent to the defect and apically to the periosteum left in place apical to the exposed bone.

The flap will be sutured using internal Horizontal mattress suture at the base of the simplified papilla and a vertical mattress suture will be placed in a more coronal position so complete soft tissue closure can be obtained.

A de-epithelialized free gingival connective tissue graft will be used to treat Cairo's recession type 2 and type 3 associated with inta-bony defects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival recession depth
Time Frame: Changes at 3 and 6 months post-operative
Measured from the cementoenamel junction to the gingival margin using a William's graduated periodontal probe. The probe will be inserted into the sulcus gently parallel to the long axis of the tooth.
Changes at 3 and 6 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic bone fill
Time Frame: At 6 months post-operative
The depth of intra-bony defect (IBD) will be measured from the alveolar bone crest to the base of the defect at baseline and after six months to detect the amount of bone fill. Individually customized bite blocks will be created for the patients using alginate impression material and acrylic resin. Parallel-angle technique will be used to obtain standardized radiographs
At 6 months post-operative
Gingival Recession Width
Time Frame: Changes at 3 and 6 months post-operative
Horizontal distance will be measured from one border of the recession to another in mesio-distal direction at CEJ level
Changes at 3 and 6 months post-operative
Percentage of Root Coverage
Time Frame: Changes at 3 and 6 months post-operative

Percentage of root coverage will be calculated by obtaining the baseline recession depth, postoperative recession depth and will be calculated according to the following formula:

(Baseline RD-6 months RD)/(Baseline RD) ×100

Changes at 3 and 6 months post-operative
Gingival Thickness
Time Frame: Changes at 3 and 6 months post-operative
Measured 2 mm apical to the gingival margin with a short needle for and a 3 mm diameter silicon disk stop. The needle is inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until resistance is found due to presence of bone. The silicone disc stop on the spreader was placed in tight contact with the external gingival tissue surface. After carefully removing the spreader, penetration depth was measured with William's periodontal probe
Changes at 3 and 6 months post-operative
Probing Depth
Time Frame: Changes at 3 and 6 months post-operative
Measured from the gingival margin to the bottom of the gingival sulcus using William's periodontal probe with the probe inserted parallel to the long axis of the tooth
Changes at 3 and 6 months post-operative
Clinical Attachment Level
Time Frame: At 3 and 6 months post-operative
Measured from the CEJ to the bottom of the gingival sulcus using William's periodontal probe.
At 3 and 6 months post-operative
Width of the Keratinized Tissue
Time Frame: At 3 and 6 months post-operative
Measured from the gingival margin to the muco-gingival junction using William's periodontal probe.
At 3 and 6 months post-operative
Post-Operative Pain
Time Frame: At 7 and 14 days post-operative
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'the most painful) measured daily for the first 2 weeks postoperatively
At 7 and 14 days post-operative
Post-Operative patient's Satisfaction
Time Frame: At 6 months post-operative
A 3-item questionnaire is asked and the patients shall use a 7-point answer scale
At 6 months post-operative
Bleeding on Probing
Time Frame: At 6 months post-operative
BOP score will be assessed as the number of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized periodontal probe with a controlled (∼25 g) force to the bottom of the sulcus at six sites (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, disto-lingual) on all present teeth
At 6 months post-operative
Plaque Index
Time Frame: At 6 months post-operative
PI will be assessed using a standardized periodontal probe to agitate the gingival margin and assessing the presence or absence of plaque at the margin. This will be recorded at 4 sites per tooth on all teeth
At 6 months post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mariam Bendary, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 13, 2020

First Posted (Actual)

August 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 30, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 14422019493595

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

study protocol, informed consent, clinical study report

IPD Sharing Time Frame

After completion of the study

IPD Sharing Access Criteria

ClinicalTrials.gov

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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