In patients planned for dental implant treatment, we will evaluate the effectiveness of improving gum tissues around dental implants in maintaining implant health and longevity and compare two materials for the same, a laboratory developed tissue substitute vs tissue taken from patients own mouth

Comparative evaluation of effectiveness of soft tissue augmentation around implants with tissue-engineered scaffold versus autogenous sub-epithelial connective tissue graft a randomized controlled study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/101565

Enrollment

Registered

2026-01-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Soft tissue augmentation using sub-epithelial connective tissue graft: Dental implant will be placed at the required site and deficient soft tissue will be augmented using autologous co

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults between 18-60 years of age. 2. Patients planned for dental implant placement. 3. Full mouth plaque scores (FMPS) and full mouth bleeding scores (FMBS) less than 20 percent after non-surgical periodontal therapy. 4. Non-smokers or former smokers (not smoked within 6 months of study initiation). 5. Ability to comply with the study-related procedures, such as exercising good oral hygiene and attending all follow-up examinations. 6. Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with clinically significant or unstable systemic diseases or compromised healing potential (i.e. connective tissue disorders or bone metabolic diseases). 2. Patients with history of antibiotic, non-steroidal anti-inflammatory medication or on drug affecting periodontal status for greater or equal to two weeks prior to enrolment in the study. 3. Pregnant or lactating women. 4. History of periodontal surgery within the last one year of enrolment.

Design outcomes

Primary

Measure	Time frame
To determine the efficacy of soft tissue augmentation in improving and/or maintaining peri-implant health (gain in thickness of peri-implant soft tissue and gain in width of attached gingiva) and esthetics (using Pink Esthetic Score).Timepoint: Width of attached gingiva and thickness of peri-implant soft-tissue - baseline (T0), after 1 month (T1), after 3 months (T2). Esthetics of peri-implant soft-tissue (Pink Esthetic Score) - baseline (T0) and after 3 months (T2).	—

Measure

Time frame

To determine the efficacy of soft tissue augmentation in improving and/or maintaining peri-implant health (gain in thickness of peri-implant soft tissue and gain in width of attached gingiva) and esthetics (using Pink Esthetic Score).Timepoint: Width of attached gingiva and thickness of peri-implant soft-tissue - baseline (T0), after 1 month (T1), after 3 months (T2). Esthetics of peri-implant soft-tissue (Pink Esthetic Score) - baseline (T0) and after 3 months (T2).

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Secondary

Measure	Time frame
To evaluate and compare the effects of tissue-engineered scaffold with FGF-2 in improving and/or maintaining peri-implant health (gain in thickness of peri-implant soft tissue and gain in width of attached gingiva) and esthetics (using Pink Esthetic Score) with those of conventional sub-epithelial connective tissue graft.Timepoint: Width of attached gingiva and thickness of peri-implant soft-tissue - baseline (T0), after 1 month (T1), after 3 months (T2). Esthetics of peri-implant soft-tissue (Pink Esthetic Score) - baseline (T0) and after 3 months (T2).;Patient perceived satisfaction and cost effectiveness of tissue engineering scaffold with FGF-2 in comparison to sub-epithelial connective tissue graft.Timepoint: After 3 months (questionnaire based)	—

Measure

Time frame

To evaluate and compare the effects of tissue-engineered scaffold with FGF-2 in improving and/or maintaining peri-implant health (gain in thickness of peri-implant soft tissue and gain in width of attached gingiva) and esthetics (using Pink Esthetic Score) with those of conventional sub-epithelial connective tissue graft.Timepoint: Width of attached gingiva and thickness of peri-implant soft-tissue - baseline (T0), after 1 month (T1), after 3 months (T2). Esthetics of peri-implant soft-tissue (Pink Esthetic Score) - baseline (T0) and after 3 months (T2).;Patient perceived satisfaction and cost effectiveness of tissue engineering scaffold with FGF-2 in comparison to sub-epithelial connective tissue graft.Timepoint: After 3 months (questionnaire based)

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Countries

India

Contacts

Public ContactDr Rameshwari Singhal

Faculty of Dental Sciences, King Georges Medical University

rameshwarisinghal@kgmcindia.edu9837400562

Outcome results