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

Recession, Gingival Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04514055
• Other study ID #: 14422019493595
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: August 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession
• Recession, Gingival

Intervention

Procedure:
• De-epithelialized connective tissue graft wall
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

Locations

Country	Name	City	State
Egypt	Faculty of dentistry Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival recession depth	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	Radiographic bone fill	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
Secondary	Gingival Recession Width	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
Secondary	Percentage of Root Coverage	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
Secondary	Gingival Thickness	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
Secondary	Probing Depth	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
Secondary	Clinical Attachment Level	Measured from the CEJ to the bottom of the gingival sulcus using William's periodontal probe.	At 3 and 6 months post-operative
Secondary	Width of the Keratinized Tissue	Measured from the gingival margin to the muco-gingival junction using William's periodontal probe.	At 3 and 6 months post-operative
Secondary	Post-Operative Pain	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
Secondary	Post-Operative patient's Satisfaction	A 3-item questionnaire is asked and the patients shall use a 7-point answer scale	At 6 months post-operative
Secondary	Bleeding on Probing	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
Secondary	Plaque Index	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