Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02788266
Status:
COMPLETED
Last Update Posted:
2016-06-02
First Post:
2016-05-27
Brief Title:
Treatment of Gingival Recession-type Defects Using Different Restorative Materials
Sponsor:
Gazi University
Organization:
Gazi University
Study Overview
Official Title:
Clinical Evaluation of Combined Surgical Restorative Treatment of Gingival Recession-type Defects Using Different Restorative Materials
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background The aim of this study was to evaluate the treatment of multiple gingival recessions associated with non-carious cervical lesions NCCL using a modified coronally advanced flap in combination with a sub-epithelial connective tissue graft SCTG on restored root surfaces
Methods Twenty-three systemically healthy subjects who were positive for the presence of three cervical lesions associated with gingival recessions in three different adjacent teeth were enrolled in the study The NCCL were each restored prior to surgery by using one of three different materials composite resin group 1 resin-modified glass ionomer cement group 2 or giomer group 3 The defects were treated with SCTG Clinical measurements including plaque index PI bleeding on probing BOP relative recession height rRH probing depth PD cervical lesion height CLH relative clinical attachment level rCAL keratinized tissue height KTH keratinized tissue thickness KTT percentage of root coverage RC and percentage of cervical lesion height coverage CLHC were recorded at baseline 3 and 6 months and 1 year postoperatively
Methods Twenty-three systemically healthy subjects who were positive for the presence of three cervical lesions associated with gingival recessions in three different adjacent teeth were enrolled in the study The NCCL were each restored prior to surgery by using one of three different materials composite resin group 1 resin-modified glass ionomer cement group 2 or giomer group 3 The defects were treated with SCTG Clinical measurements including plaque index PI bleeding on probing BOP relative recession height rRH probing depth PD cervical lesion height CLH relative clinical attachment level rCAL keratinized tissue height KTH keratinized tissue thickness KTT percentage of root coverage RC and percentage of cervical lesion height coverage CLHC were recorded at baseline 3 and 6 months and 1 year postoperatively
Detailed Description:
Gingival recession GR is defined as exposure of the root surface due to displacement of the gingival margin apical to the cemento-enamel junction CEJ Problems related to gingival recessions are dentin hypersensitivity bacterial plaque accumulation difficulty of maintaining oral health care and aesthetics root caries and abrasions and fear of losing teeth6 Coronally advanced flap CAF is an effective periodontal plastic surgical procedure for the treatment of gingival recessions The CAF with a subepithelial connective tissue graft CAF SCTG technique is reported as the gold standard and does enhance the probability of achieving complete root coverage
Various dental materials and surgical approaches have been used to manage gingival recessions associated with cervical lesions for the most predictable combined surgicalrestorative treatmentRestorative materials must be biocompatible to minimize their adverse effects on periodontal tissues induced by direct contactResin composites or resin modified glass ionomer cements have been commonly used to restore cervical lesionsResin-ionomer materials have many properties such as biocompatibility with soft and hard tissues and displaying high marginal adaptation and minimal surface roughness as well as allowing them to be used successfully in the subgingival region Composite resin materials have many advantages including aesthetics and surface characteristics in terms of finishing and polishing
It has been reported that well-adapted and finished composite resins seem have no adverse effects on the periodontal margin It has also been reported that the ageing of the composite resin restorations may produce gingival inflammation in subgingival areas Fluoride-releasing resin materials with pre-reacted glass PRG called giomer has been suggested to have good color matching biocompatibility smooth surface finish fluoride release and fluoride recharge potential It was reported in a randomized-controlled clinical trial that the use of CTG for treatment of root surfaces restored with giomer was effective over the 6-month period without any noxious effect on periodontal tissues
Therefore the aim of this study was to evaluate clinically the treatment of gingival recession associated with NCCL in resin modified glass ionomer cement RMGI or nano-filled resin composite NRC or giomer plus SCTG in the first year following surgery
Various dental materials and surgical approaches have been used to manage gingival recessions associated with cervical lesions for the most predictable combined surgicalrestorative treatmentRestorative materials must be biocompatible to minimize their adverse effects on periodontal tissues induced by direct contactResin composites or resin modified glass ionomer cements have been commonly used to restore cervical lesionsResin-ionomer materials have many properties such as biocompatibility with soft and hard tissues and displaying high marginal adaptation and minimal surface roughness as well as allowing them to be used successfully in the subgingival region Composite resin materials have many advantages including aesthetics and surface characteristics in terms of finishing and polishing
It has been reported that well-adapted and finished composite resins seem have no adverse effects on the periodontal margin It has also been reported that the ageing of the composite resin restorations may produce gingival inflammation in subgingival areas Fluoride-releasing resin materials with pre-reacted glass PRG called giomer has been suggested to have good color matching biocompatibility smooth surface finish fluoride release and fluoride recharge potential It was reported in a randomized-controlled clinical trial that the use of CTG for treatment of root surfaces restored with giomer was effective over the 6-month period without any noxious effect on periodontal tissues
Therefore the aim of this study was to evaluate clinically the treatment of gingival recession associated with NCCL in resin modified glass ionomer cement RMGI or nano-filled resin composite NRC or giomer plus SCTG in the first year following surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None