Gingival Recession and Oral Health-related Quality of Lif... | NCT07557277

Studies
Gingival Recession and Oral Health-related Quality of Life: A Cross-sectional Study

NCT07557277

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Status

Recruiting

Last Update Posted

Apr 29, 2026Actual

Enrollment

346Estimated

Phase

Not provided

Conditions

Gingival Recession

Interventions

Systemically healthy individuals 18-45 years of age, having gingival recession

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2026Actual

Primary Completion Date

Dec 15, 2026Estimated

Completion Date

Mar 15, 2027Estimated

First Submitted Date

Apr 22, 2026

First Submission Date that Met QC Criteria

Apr 22, 2026

First Posted Date

Apr 29, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2026

Last Update Posted Date

Apr 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Aim of this study is the assessment of gingival recession and its impact on oral health related quality of life in tertiary health care center in Haryana state.

Objectives:

Determine the prevalence of gingival recession (GR) through clinical screening.
Classify patients with GR based on the system proposed by Cairo et al.
Identify the risk factors associated with GR
To assess the impact of GR on oral health related quality of life.

Detailed Description

The World Health Organization (WHO) emphasizes a holistic approach to health. According to WHO health is "a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity". Gingival recession is the migration of gingival margin apical to cementoenamel junction. Gingival recession although not associated with increased tooth loss, is considered an esthetic concern to patients. It is associated with the occurrence of dentin hypersensitivity and carious/non-carious cervical lesions on the exposed root surface. Most of the studies reported prevalence of gingival recession, but in specific geographic locations. Thus, this study aimed to assess the prevalence of gingival recession and its impact on oral health related quality of life in a sample of north Indian population in Haryana state.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

346Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Systemically healthy individuals 18-45 years of age, having gingival recession	Other	Oral health related quality of life will be recorded using oral health impact profile-14 questionnaire in patients having gingival recession

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oral health quality assessment	Oral health quality assessment will be recorded using oral health impact profile-14 questionnaire.	12 months
Prevalence of gingival recession	Prevalence of gingival recession will be categorised based on Cairo classification.	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-45 years old;
Patients who are willing to participate in the study and ready to give informed consent.
Cases defined for GR will be done according to Cairo at el.
The minimum threshold for reporting the presence of gingival recession will be greater than or equal to 1 mm.

Exclusion Criteria:

Systemic disease affecting the periodontal issues (e.g., bleeding disorders, diabetes mellitus etc.)
Patients under medication associated with gingival enlargement (e.g., calcium channel blockers, immunosuppressants or anticonvulsants).
Patients having masochistic habits (tongue thrusting, nail biting etc.)
Mobile teeth
Involved teeth with trauma from occlusion.
Involved teeth with prosthesis.
Endodontically involved/ RCT treated tooth
Patient undergoing/underwent orthodontic treatment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Systemically healthy individuals having gingival recession of north Indian population in Haryana state.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sanjay Tewari, MDS	Contact	262283876	911	principal.pgids@uhsr.ac.in
Shikha Tewari, MDS	Contact	9416514600	91	drshikhatewari@yahoo.com

Overall Officials

Name	Affiliation	Role
Sakshi Malhotra, MDS	PGIDS, Rohtak	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PGIDS, Rohtak	Recruiting	Rohtak	Haryana	124001	India

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005889	Gingival Recession

Ancestor Terms

ID	Term
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000375	Aging

Ancestor Terms

ID	Term
D048788	Growth and Development
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided